510(k) K203440 ยท NRY Catheter, Thrombus Retriever
Penumbra System (Reperfusion Catheter RED 62)
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, May 20, 2021 |
| Received | Nov 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2026 | Penumbra Inc. Brand Name: Penumbra System (RED 62 Reperfusion Catheter)
Product Name: Penumbra System (RED 62 Reperfusion Catheter)
Model/Catalog Number: THNDRRED62SKIT
Software Version: N/A
Product Description: Pr Open, Classified |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.