510(k) K052509 ยท HCG Device, Neurovascular Embolization
M-BOLUS EMBOLIC MICROSPHERES
| Applicant | Scion Cardio-Vascular, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Dec 11, 2006 |
| Received | Sep 13, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K052509
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.