510(k) K250690 ยท NRY Catheter, Thrombus Retriever
Penumbra System (Thunderbolt Aspiration Tubing)
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Jun 10, 2026 |
| Received | Mar 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250690
| 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.