510(k) K193244 · QEW Peripheral Mechanical Thrombectomy With Aspiration
Indigo Aspiration System Lightning Aspiration Tubing
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Mar 13, 2020 |
| Received | Nov 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193244
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.