510(k) K983162 ยท FTM Mesh, Surgical
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
| Applicant | Bio-Vascular, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Oct 9, 1998 |
| Received | Sep 10, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983162
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2024 | Baxter Healthcare Corporation Baxter Peri-Guard Repair Patch (legacy product codes):
a) PC0404NBIO,
b) PC0608NBIO,
c) PC0814NBIO,
d) PC1016NBIO Open, Classified |
FTM | None listed |
| Mar 26, 2024 | Baxter Healthcare Corporation Baxter Supple Peri-Guard Repair Patch (legacy product codes):
a) PC0404SNBIO,
b) PC0608NSBIO,
c) PC0814SNBIO,
d) PC1016SNBIO Open, Classified |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.