510(k) K983602 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
CV PERI-GUARD AND VASCU-GUARD
| Applicant | Bio-Vascular, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Nov 12, 1998 |
| Received | Oct 13, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Baxter Healthcare Corporation Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes:
a) VG0108N: 0.8X8 CM GLOBAL,
b) VG0110N: 1X10 CM GLOBAL,
c) VG0106N: 1X6 CM GLOBAL,
d) VG0209N: 2X9 CM GLOBAL Open, Classified |
DXZ | None listed |
| Aug 12, 2016 | Baxter Healthcare Corp. Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes:
1 cm x 6 cm, product code VG0106N,
0.8 cm x 8 cm, product code VG0108N,
1 cm x 10 cm, product code VG0110N, a Terminated |
DXZ | None listed |
| Nov 18, 2013 | Synovis Surgical Innovations, Inc. Vascu Guard, Peripheral Vascular Patch with Apex Processing.
For use in peripheral vascular reconstruction.
Product Code:
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
V Terminated |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.