510(k) K193595 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Aug 19, 2020 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193595
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.