510(k) K883696 ยท DXC Clamp, Vascular
FLO-RESTER
| Applicant | Bio-Vascular, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Nov 30, 1988 |
| Received | Aug 30, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883696
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes:
a) Product Code 50100: 12MM, 1.00 MM GLOBAL;
b) Product Code 50150: 12MM, 1.50 MM GLOBAL;
c) Product Cod Open, Classified |
DXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.