Brand Name | BAXTER LIFESPAN EPTFE VASCULAR GRAFT |
Type of Device | VASCULAR GRAFT |
Baseline Brand Name | LIFESPAN EPTFE VASCULAR GRAFT |
Baseline Generic Name | VASCULAR GRAFT |
Baseline Catalogue Number | NA |
Baseline Model Number | BV06040 |
Baseline Device Family | VASCULAR GRAFT - STRAIGHT |
Baseline Device 510(K) Number | K933590 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 60 |
Date First Marketed | 03/08/1995 |
Manufacturer (Section F) |
BAXTER HEALTHCARE CORP. |
17221 red hill avenue |
irvine CA 92614 |
|
Manufacturer (Section D) |
BAXTER HEALTHCARE CORP. |
17221 red hill avenue |
irvine CA 92614 |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE CORP. |
17221 red hill ave. |
|
irvine CA 92614 |
|
Manufacturer Contact |
allison
mezzanatto
|
one edwards way |
irvine
, CA 92614-5686 |
(949)
250
-2562
|
|
Device Event Key | 100267 |
MDR Report Key | 101883 |
Event Key | 95771 |
Report Number | 6000002-1997-00553 |
Device Sequence Number | 1 |
Product Code | DSY |
Report Source |
Manufacturer
|
Source Type |
Study,User facility,Company Representative
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/27/1997 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 06/26/1997 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device EXPIRATION Date | 12/01/1999 |
Device MODEL Number | BV06040 |
Device LOT Number | 4K1562 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Device Age | 2 yr |
Event Location |
Hospital
|
Date Report TO Manufacturer | 05/27/1997 |
Date Manufacturer Received | 05/27/1997 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 12/01/1994 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|