510(k) K963967 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
GLYCAR PERICARDIAL PATCH
| Applicant | Glycar, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Oct 31, 1997 |
| Received | Oct 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963967
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2025 | Glycar SA Pty., Ltd. SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE Open, Classified |
DXZ | None listed |
| Nov 25, 2025 | Glycar SA Pty., Ltd. SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE Open, Classified |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.