510(k) K090932 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000
| Applicant | Nexgen Medical Systems, Inc., Reno NV, US |
| Decision | Substantially Equivalent, Sep 24, 2009 |
| Received | Apr 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090932
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.