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ATTACHMENT BADVISORY LIST OF HIGH RISK DEVICES* THAT ARE INTENDED FOR SURGICAL IMPLANT OR SUSTAINING LIFE ANESTHESIOLOGY DEVICES Page 2CARDIOVASCULAR DEVICES Page 3DENTAL DEVICES Page 6EAR, NOSE, AND THROAT DEVICES Page 6GASTROENTEROLOGY-UROLOGY DEVICES Page 6GENERAL AND PLASTIC SURGERY DEVICES Page 8GENERAL HOSPITAL AND PERSONAL USE DEVICES Page 8NEUROLOGICAL DEVICES Page 9OBSTETRICAL AND GYNECOLOGICAL DEVICES Page 11OPHTHALMIC DEVICES Page 11 ORTHOPEDIC DEVICES Page 11*SUPPLEMENTAL INFORMATION (#)Dialysis Systems & AccessoriesPeritoneal Dialysis Systems and Accessories Page 17Hemodialysis Systems and Accessories Page 18 *High Risk Devices are Class III and Class II devices that are life-sustaining/life-supporting devices (based on the Advisory List of Critical Devices – Federal Register, March 17, 1988) or significant risk devices, as defined by 21 CFR 812.3(m) for Investigational Devices Exemptions.NOTE: The Quality System Regulation no longer refers to critical devices. However, 21 CFR 820.65 requires traceability for all devices that meet the same definition as devices on the Advisory List of Critical Devices - 1988.PART 868 -- ANESTHESIOLOGY DEVICESDevice No. on CFR or Classification Name Original Former device name, or FR Cite of Device List Additional Information 1. 868.1200 Indwelling blood oxygen 5 Analyzer, oxygen, partial pressure (P02) Neonatal Invasive analyzer. 2. 868.2375 Breathing frequency -- Apnea monitor. monitor. 3. 868.5090 Emergency airway needle. 43 Needle, emergency airway. 4. 868.5160(a) Gas machine for anes- 42 Machine, gas anesthesia/ thesia analgesia, complete systems. Section 868. 5160(b) Gas machine for analgesia is exempt from critical device requirements. 5. 868.5240 Anesthesia breathing 19 Circuit, breathing (w/ circuit. connector, adaptor y-piece). 6. 868.5400 Electroanesthesia 6,62 Apparatus, electroanesthesia; apparatus. and stimulator, electroanesthesia. 7. 868.5440 Portable oxygen 32 Generator, oxygen, generator. portable. #See Pg 25 8. 868.5470 Hyperbaric chamber. -- --- (Monoplace) 9. 868.5610 Membrane lung for long- 41 Lung, membrane (for long-term term pulmonary support. pulmonary support). 10. 868.5650 Esophageal obturator. 2 Airway, esophageal (obturator). 11. 868.5720 Bronchial tube. 66 Tube, bronchial (w/wo connector). 12. 868.5730 Tracheal tube. 67 Tube, tracheal (w/wo connector). 13. 868.5740 Tracheal/bronchial 68 Tube, tracheal/bronchial, differential ventila- differential/ventilation tion tube. (w/wo connector). 14. 868.5750 Inflatable tracheal 27 Cuff, tracheal tube, inflatable. tube cuff. 15. 868.5800 Tracheostomy tube and 69 Tube, tracheostomy tube cuff. (w/wo connector). 16. 868.5810 Airway connector. 25 Connector, airway (extension). 17. 868.5830 Autotransfusion apparatus. 9 Autotransfusion apparatus. 18. 868.5895 Continuous ventilator. 73,56 Ventilator, continuous (respirator) and respirator, neonatal ventilator 19. 868.5905 Noncontinuous 75 Ventilator, noncontinuous ventilator (IPPB). (respirator). 20. 868.5915 Manual emergency 58,70 Manual emergency ventilator; ventilator. and resuscitator, pulmonary, manual. 21. 868.5925 Powered emergency 70 Unit emergency oxygen and ventilator. resuscitation. 22. 868.5935 External negative 74 Ventilator, external body negative pressure ventilator. pressure, adult (cuirass). PART 870 - CARDIOVASCULAR DEVICES 23. 870.1025 Arrhythmia detector 29 Detector and alarm, and alarm. arrhythmia. 24. 870.1330 Catheter guide wire. -- For use with percutaneous transluminal coronary angioplasty catheters. (See #56.) 25. 870.1360 Trace microsphere. -- --- 26. 870.1750 External programmable 34 Generator, pulse, pace- pacemaker pulse maker, external, generator. programmable. 27. 870.1800 Withdrawal-infusion 54 Pump, withdrawal/ pump. infusion. 28. 870.3250 Vascular clip. 22 Clip, vascular. 29. 870.3260 Vena cava clip. 23 Clip, vena cava. 30. 870.3300 Arterial embolization -- --- device. 31. 870.3375 Cardiovascular 31 Filter, intravascular, intravascular filter. cardiovascular 32. 870.3450 Vascular graft 47,52 Prosthesis, arterial graft prosthesis of less than synthetic, and prosthesis 6-millimeters diameter. vascular graft. 33. 870.3460 Vascular graft 47,52 Prosthesis, arterial graft prosthesis of 6 milli- synthetic, and prosthesis, meters and greater diameter. vascular graft. 34. 870.3470 Intracardiac patch or -- --- pledget made of poly- propylene, polyethylene polyethylene tere- phthalate, or polytetra- fluoroethylene. 35. 870.3535 Intra-aortic balloon and 10 Balloon, intra-aortic, control system. and control system. 36. 870.3545 Ventricular bypass 15 Bypass, ventricular (assist) device. (assist). 37. 870.3600 External pacemaker 33 Generator, pulse, Pulse generator. pacemaker, external. 38. 870.3610 Implantable pacemaker 35 Generator, pulse, pace- pulse generator. maker, implantable. 39. 870.3620 Pacemaker lead adaptor. -- --- 40. 870.3650 Pacemaker polymeric -- --- mesh bag. 41. 870.3670 Pacemaker charger. -- --- 42. 870.3680 Cardiovascular permanent 30 Electrode, pacemaker, or temporary pacemaker, permanent and temporary electrode. 43. 87O.3700 Pacemaker programmers. -- --- 44. 870.3710 Pacemaker repair or -- --- replacement material. 45. 870.3800 Annuloplasty ring. -- --- 46. 870.3850 Carotid sinus nerve -- --- stimulator. 47. 870.3925 Replacement heart valve. 71 Valve, heart replacement. 48. 870.4320 Cardiopulmonary -- --- bypass pulsatile flow generator. 49. 870.4350 Cardiopulmonary 44 Oxygenator, cardiopulmonary. bypass oxygenator. 50. 870.4360 Nonroller-type 13 Blood pump, cardiopulmonary cardiopulmonary bypass bypass, non-roller. blood pump. 51. 870.4370 Roller-type 14 Blood pump, cardiopulmonary cardiopulmonary bypass roller type. bypass blood pump. 52. 870.5200 External cardiac 24,57 Compressor, external, cardiac compressor. powered, and resuscitator, cardiac mechanical. 53. 870.5225 External counter- 26 Counter-pulsating device, pulsating device. external. 54. 870.5300 DC-defibrillator 28 Defibrillator, DC-powered (including paddles). (including paddles).
55. 870.5550 External transcutaneous 45 Pacemaker, cardiac, external cardiac pacemaker transcutaneous. (noninvasive). 56. --- Percutaneous transluminal -- Premarket approval device. coronary angioplasty (PTCA) balloon dilation catheter. 57. --- Automatic Implanted -- Premarket approval device. Cardioverter Defibril- lator System. PART 872 -- DENTAL DEVICES 58. 872.3640 Endosseous implant. -- ---
PART 874 -- EAR, NOSE, AND THROAT DEVICES 59. 874.3620 Ear, nose and throat -- --- synthetic polymer material. 60. 874.3695 Mandibular implant -- --- facial prosthesis. 61. 874.3730 Laryngeal prosthesis 49 Prosthesis, Laryngeal (Taub design). 62. 874.3820 Endolymphatic shunt -- --- 63. 874.3850 Endolymphatic shunt tube -- --- with valve. 64. 874.3930 Tympanostomy tube with -- --- semipermeable membrane 65. --- Ear, nose, throat natural -- Pre-Amendments Device; polymer - collagen not classified. material. PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES 66. 876.3350 Penile inflatable implant. -- --- 66a 876.3630 Penile rigidity implant -- --- 67. 876.5270 Implanted electrical -- --- urinary continence device. 68. 876.5540 A-V shunt cannula. -- Included in blood access device and accessories. 69. 876.5630 # Peritoneal dialysis 46 Peritoneal dialysis system, system and accessories. automatic delivery 70. 876.5820 # Hemodialysis system and 36 Dialysate concentrate added. and accessories. Dialysate concentrate Hollow fiber capillary dialyzers Disposable dialyzers High permeability dialyzers Parallel flow dialyzers Single needle dialysis set Dialysate delivery system # See charts showing the critical/noncritical breakdown of peritoneal and hemodialysis systems on pages 17 and 18 of Attachment B. 70A 876.5860 # High permeability Dialysate concentrate added. hemodialysis system. 36 71. 876.5870 Sorbent hemoperfusion 7 Apparatus, hemoperfusion, system. sorbent. 72. 876.5880 Isolated kidney perfusion -- --- and transport system and accessories. 73. 876.5955 Peritoneo-venous shunt. -- --- 74. 46 FR 7566 Urethral sphincter 51 Prosthesis, urethra sphincter; (1/23-/81) prosthesis. device-not known to be in commercial distribution. 75. 46 FR 7566 Urethral replacement 55 Replacement, urethral. (1/23/81) Device not known to be in commercial distribution. PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES (The following are class III devices. See 21 U.S.C. 360j(l).) 76. 42 FR 63474 Absorbable surgical -- Class III transitional (12/16/77) sutures. device. 77. 42 FR 63474 Nonabsorbable surgical -- Class III transitional (12/16/77) sutures. device. 78. 879.4520 Polytetrafluoroethylene -- Class III transitional (Teflon) injectable. device.
79. 878.3300 Surgical mesh. -- ---
80. 878.3500 Polytetrafluoroethylene -- --- with carbon fibers composite implant material. 81. 878.3530 Inflatable breast -- --- prosthesis 82. 878.3540 Silicone gel-filled breast -- --- prosthesis. 83. --- Implanted mammary 510(k) device. prosthesis of composite saline and gel-filled design. 84. 878.3610 Esophageal prosthesis. 48 Prosthesis, esophagus. 85. 878.3720 Tracheal prosthesis. 50 Prosthesis, trachea. 86. 878.4300 Implantable clip. -- --- 87. 878.4750 Implantable staple. -- --- 88. --- Maxillofacial prosthesis. -- ENT facial prosthesis, maxillofacial. PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES 89. 880.5130 Infant radiant warmer. 12 Bed, radiant heat. 90. 880.5400 Neonatal incubator. 37 Incubator, neonatal ventilator. 91. 880.5410 Neonatal transport -- --- incubator. 92. 880.5725 Infusion pump. 53 Term "cardiovascular" dropped since not used in classification regulation and devices not marketed as "cardiovascular infusion pumps." 93. -- Implanted infusion pump. -- Premarket approval device. PART 882 - NEUROLOGICAL DEVICES 94. 882.5030 Methyl methacrylate for -- --- aneurysmorrhaphy. 95. 882.5150 Intravascular occluding 17 Catheter, intravascular catheter. occluding. 96. 882.5200 Aneurysm clip. 20 Clip, aneurysm. 97. 882.5225 Implanted malleable clip. -- --- 98. 882.5250 Burr hole cover. -- --- 99. 882.5300 Methyl methacrylate for -- --- cranioplasty. 100. 882.5320 Preformed alterable -- --- cranioplasty plate. 101. 882.5330 Preformed nonalterable -- --- cranioplasty plate. 102. 882.5360 Cranioplasty plate fastener. -- --- 103. 882.5550 Central nervous system 59 Shunt, central nervous fluid shunt and components. system fluid and components. 104. 882.5820 Implanted cerebellar 60 Stimulator, cerebella, stimulator. implanted. 105. 882.5830 Implanted diaphragmatic/ 61 Stimulator, diaphragmatic/ phrenic nerve stimulator. phrenic nerve, implanted. 106. 882.5840 Implanted intracerebral/ 63 Stimulator, intracerebral/ subcortical stimulator subcortical, implanted for pain relief. (pain relief). 107. 882.5850 Implanted spinal cord -- --- stimulator for bladder evacuation. 108. 882.5860 Implanted neuromuscular -- --- stimulator. 109. 882.5870 Implanted peripheral nerve -- --- stimulator for pain relief. 110. 882.5880 Implanted spinal cord -- --- stimulator for pain relief. 111. 882.5880 Epidural spinal electrode. -- Component of Implanted spinal cord stimulator for pain relief (#110). 112. 882.5900 Preformed craniosynostosis -- --- strip. 113. 882.5910 Dura substitute. -- --- 114. 882.5950 Artificial embolization 65 Thromboemboli, intravascular device. (artificial embolization device). 115. --- Lyophilized human -- Pre-Amendments device; (cadaver) dura mater. not classified. 116. --- Stabilized epidural spinal -- Premarket approval electrode. device. 117. --- Implanted intracranial -- Premarket approval pressure monitor. device. 118. --- Totally implanted spinal -- Premarket approval cord stimulator for pain device. relief.
PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES 119. 884.5360 Contraceptive intrauterine 38 Intrauterine contraceptive device (IUD) and intro- device (IUD) and introducer. ducer. 120. 884.5380 Contraceptive tubal 11 Band, tubal occlusion; occlusion device (TOD) 21 Clip, tubal Occlusion; and introducer. 72 Valve, tubal occlusion. PART 886 - OPHTHALMIC DEVICES 121. 886.3300 Absorbable implant -- --- (scleral buckling method) 122. 886.3400 Keratoprosthesis 39 Keratoprosthesis, non-custom 123. 886.3600 Intraocular lens 40 Lens, intraocular, ophthalmic; Class III transitional device. 124. 886.3920 Eye valve implant -- --- PART 888 ORTHOPEDIC DEVICES 125. 888.3000 Bone Cap. -- --- 126. 888.3010 Bone fixation cerclage. -- --- 127. 888.3020 Intramedullary fixation -- --- rod. 128. 888.3025 Passive tendon prosthesis. -- --- 129. 888.3027 Polymethylmethacrylate -- Class III transitional (PMMA) bone cement. device. 130. 888.3030 Single/multiple component -- --- metallic bone fixation appliances and acces- sories. 131. 888.3040 Smooth or threaded -- --- metallic bone fixation fastener. 132. 888.3050 Spinal interlaminal -- --- fixation orthosis. 133. 888.3060 Spinal intervertebral body -- --- fixation orthosis. 134. 888.3100 Ankle joint metal/composite -- --- semi-constrained cemented prosthesis. 135. 888.3110 Ankle joint metal/polymer -- --- semi-constrained cemented prosthesis. 136. 888.3120 Ankle joint metal/polymer -- --- non-constrained cemented prosthesis. 137. 888.3150 Elbow joint metal/metal or -- --- metal/polymer constrained cemented prosthesis. 138. 888.3160 Elbow joint metal/polymer -- --- semi-constrained cemented prosthesis. 139. 888.3170 Elbow joint radial (hemi- -- --- elbow) polymer prosthesis. 140. 888.3180 Elbow joint humeral (hemi- -- --- elbow) metallic uncemented prosthesis. 141. 888.3200 Finger joint metal/metal -- --- constrained uncemented prosthesis. 142. 888.3210 Finger joint metal/metal -- --- constrained cemented prosthesis. 143. 888.3220 Finger joint metal/polymer -- --- constrained cemented prosthesis. 144. 888.3230 Finger joint polymer con- -- --- strained prosthesis. 145. 888.3300 Hip joint metal constrained -- --- cemented or uncemented prosthesis. 146. 888.3310 Hip joint metal/polymer -- --- constrained cemented or uncemented prosthesis. 147. 888.3320 Hip joint metal/metal -- --- semi-constrained, with a cemented acetabular component, prosthesis. 148. 888.3330 Hip joint metal/metal -- --- semi-constrained, with an uncemented acetabular component, prosthesis. 149. 888.3340 Hip joint metal/composite -- --- semi-constrained cemented prosthesis. 150. 888.3350 Hip joint metal/polymer -- --- semi-constrained cemented prosthesis. 151. 888.3360 Hip joint femoral (hemi- -- --- hip) metallic cemented or uncemented prosthesis. 152. 888.3370 Hip joint (hemi-hip) -- --- acetabular metal cemented prosthesis. 153. 888.3380 Hip joint femoral (hemi- -- --- hip) trunnion-bearing metal/polyacetal cemented prosthesis. 154. 888.3390 Hip joint femoral (hemi-hip) -- --- metal/polymer cemented or uncemented prosthesis. 155. 888.3400 Hip joint femoral (hemi- -- --- hip) metallic resurfacing prosthesis. 156. 888.3410 Hip joint metal/polymer -- --- semi-constrained resur- facing cemented prosthesis. 157. 888.3480 Knee joint femorotibial -- --- metallic constrained cemented prosthesis. 158. 888.3490 Knee joint femorotibial -- --- metal/composite non- constrained cemented prosthesis. 159. 888.3500 Knee joint femorotibial -- --- metal/composite semi- constrained cemented prosthesis. 160. 888.3510 Knee joint femorotibial -- --- metal/polymer con- strained cemented prosthesis. 161. 888.3520 Knee joint femorotibial -- --- metal/polymer non- constrained cemented prosthesis. 162. 888.3530 Knee joint femorotibial -- --- metal/polymer semi- constrained cemented prosthesis. 163. 888.3540 Knee joint patellofemoral -- --- polymer/metal semi- constrained cemented prosthesis.
164. 888.3550 Knee joint patellofemoro- -- --- tibial polymer/metal/ metal constrained cemented prosthesis. 165. 888.3560 Knee joint patellofemoro- -- --- tibial polymer/metal/ polymer semi-constrained cemented prosthesis. 166. 888.3570 Knee joint femoral (hemi- -- --- knee) metallic uncemented prosthesis. 167. 888.3580 Knee joint patellar (hemi- -- --- knee) metallic resur- facing uncemented prosthesis. 168. 888.3590 Knee joint tibial (hemi- -- --- knee) metallic resur- facing uncemented prosthesis. 169. 888.3640 Shoulder joint metal/metal -- --- or metal/polymer constrained cemented prosthesis. 170. 888.3650 Shoulder joint metal/ -- --- polymer non-constrained cemented prosthesis. 171. 888.3660 Shoulder joint metal/ -- --- polymer semi-constrained cemented prosthesis. 172. 888.3680 Shoulder Joint glenoid -- --- (hemi- shoulder) metallic cemented prosthesis. 173. 888.3690 Shoulder joint humeral -- --- (hemi- shoulder) metallic uncemented prosthesis.
174. 888.3720 Toe joint polymer con- -- --- strained prosthesis. 175. 888.3730 Toe joint phalangeal -- --- (hemi-toe) polymer prosthesis. 176. 888.3750 Wrist joint carpal lunate -- --- polymer prosthesis. 177. 888.3760 Wrist joint carpal scaphoid -- --- Polymer prosthesis. 178. 888.3770 Wrist joint carpal trape- -- --- zium polymer prosthesis. 179. 888.3780 Wrist joint polymer con- -- --- strained prosthesis. 180. 888.3790 Wrist joint metal con- -- --- strained cemented prosthesis. 181. 888.3800 Wrist joint metal/polymer -- --- semi-constrained cemented prosthesis. 182. 888.3810 Wrist joint ulnar (hemi- -- --- wrist) polymer prosthesis. |
PERITONEAL DIALYSIS SYSTEMS AND ACCESSORIES
HEMODIALYSIS SYSTEMS AND ACCESSORIES
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