510(k) K122543 ยท KRD Device, Vascular, For Promoting Embolization
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Nov 28, 2012 |
| Received | Aug 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122543
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.