510(k) K091458 ยท MJN Catheter, Intravascular Occluding, Temporary
HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104
| Applicant | Ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 15, 2009 |
| Received | May 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091458
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.