510(k) K092495 ยท MJN Catheter, Intravascular Occluding, Temporary
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
| Applicant | Ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 22, 2009 |
| Received | Aug 14, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092495
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.