510(k) K811276 ยท DYG Catheter, Flow Directed
OCCLUSION CATHETER
| Applicant | Bionomy, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 30, 1981 |
| Received | May 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2025 | LeMaitre Vascular, Inc. Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56 Open, Classified |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.