510(k) K100063 ยท MJN Catheter, Intravascular Occluding, Temporary
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
| Applicant | Ev3, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 2, 2010 |
| Received | Jan 11, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100063
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.