510(k) K211411 ยท NRY Catheter, Thrombus Retriever
Penumbra System (RED 68 Reperfusion Catheter)
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Jul 1, 2021 |
| Received | May 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | Penumbra, Inc. Penumbra System RED 68 Reperfusion Catheter
REF: RED68KIT Open, Classified |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.