510(k) K180412 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, May 15, 2018 |
| Received | Feb 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180412
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.