510(k) K221032 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
Vascu-Guard Vascular Repair Patch
| Applicant | Synovis Life Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 19, 2022 |
| Received | Apr 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Baxter Healthcare Corporation Vascu-Guard Peripheral Vascular Patch (US), Product Codes:
a) VG0108: 0.8 X 8 CM US, TS;
b) VG0110: 1 X 10 CM US, TS;
c) VG0106: 1 X 6 CM US, TS;
d) VG0209: 2 X 9 CM US, TS Open, Classified |
PSQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.