Brand Name | TRU-TRAC DILATATION CATH |
Type of Device | PTA CATHETER |
Baseline Brand Name | BARD TRUTRAC PTA BALLOON DILATATION CATHETER |
Baseline Generic Name | VESSEL DILATOR |
Baseline Catalogue Number | 0058564 |
Baseline Device Family | ANGIOPLASTY CATHETERS |
Baseline Device 510(K) Number | K830608 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
No
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Date First Marketed | 01/01/1986 |
Manufacturer (Section F) |
C.R. BARD, BPT DV |
13183 harland dr. ne |
covington GA 30014 |
|
Manufacturer (Section D) |
C.R. BARD, BPT DV |
13183 harland dr. ne |
covington GA 30014 |
|
Manufacturer (Section G) |
VAS-CATH |
2380 teldo street |
|
mississauga, ont |
CANADA
L5A 3V3
|
|
Manufacturer Contact |
cindy
luttrell
|
13183 harland dr. ne |
covington
, GA 30014 |
(770)
385
-2337
|
|
Device Event Key | 237466 |
MDR Report Key | 245108 |
Event Key | 229936 |
Report Number | 1058665-1999-00046 |
Device Sequence Number | 1 |
Product Code | LIT |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/17/1999 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 10/15/1999 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0058564 |
Device LOT Number | 44GIA026 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Device Age | 14 mo |
Event Location |
Hospital
|
Date Manufacturer Received | 09/17/1999 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 07/01/1998 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|