510(k) K110315 ยท QEZ Aspiration Thrombectomy Catheter
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
| Applicant | Nexgen Medical Systems, Inc., Melbourne FL, US |
| Decision | Substantially Equivalent, Oct 20, 2011 |
| Received | Feb 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110315
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.