510(k) K222358 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Indigo Aspiration System - Lightning Flash
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Dec 20, 2022 |
| Received | Aug 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222358
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.