Brand Name | GOODTEC THERMODILUTION BALLOON CATHETER |
Type of Device | FLOW-DIRECTED BALLOON THERMODILUTION CATHETER |
Baseline Brand Name | GOODTEC BALLOON THERMODILUTION CATHETER |
Baseline Generic Name | FLOW-DIRECTED BALLOON THERMODILUTION CATHETER |
Baseline Catalogue Number | 417D1014/I |
Baseline Model Number | T147 |
Other Baseline ID Number | PN604057 |
Baseline Device Family | THERMODILUTION CATHETER (PUR) |
Baseline Device 510(K) Number | K841639 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 24 |
Date First Marketed | 08/12/1984 |
Manufacturer (Section F) |
B. BRAUN MEDICAL, INC/CARDIOVASCULAR DIV |
18 olney ave., bldg. #44 |
cherry hill NJ 08003 1607 |
|
Manufacturer (Section D) |
B. BRAUN MEDICAL, INC/CARDIOVASCULAR DIV |
18 olney ave., bldg. #44 |
cherry hill NJ 08003 1607 |
|
Manufacturer (Section G) |
B. BRAUN MEDICAL, INC. |
1940 olney ave, ste 200 |
|
cherry hill NJ 08003 1607 |
|
Manufacturer Contact |
chris
watt
|
18 olney ave., bldg. #44 |
cherry hill
, NJ 08003-1607 |
(609)
751
-2080
ext 114
|
|
Device Event Key | 167748 |
MDR Report Key | 172505 |
Event Key | 162115 |
Report Number | 2243801-1998-00020 |
Device Sequence Number | 1 |
Product Code | DYG |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/14/1998 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 06/12/1998 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
UNKNOWN
|
Device EXPIRATION Date | 10/31/1999 |
Device MODEL Number | T147 |
Device Catalogue Number | 417D1014/I |
Device LOT Number | M476660 |
OTHER Device ID Number | PN604057 |
Was Device Available For Evaluation? |
Yes
|
Date Returned to Manufacturer | 05/14/1998 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 05/14/1998 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/1997 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|