510(k) K221029 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD 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 K221029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Baxter Healthcare Corporation Peri-Guard Repair Patch, Product Codes:
a) PG1016 : 10 X 16 CMUS, TS
b) PG1225: 12 X 25 CMUS, TS
c) PG0404: 4 X 4 CMUS, TS
d) PG0608: 6 X 8CMUS, TS
e) PG0814: 8 X 14 CMUS, 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.