510(k) K160533 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
| Applicant | Penumbra, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, May 24, 2016 |
| Received | Feb 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160533
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.