510(k) K180105 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Mar 8, 2018 |
| Received | Jan 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180105
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.