510(k) K090728 ยท MJN Catheter, Intravascular Occluding, Temporary
HYPERGLIDE OCCLUSION BALLOON SYSTEM
| Applicant | Ev3, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 16, 2009 |
| Received | Mar 19, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090728
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.