510(k) K001237 ยท MJN Catheter, Intravascular Occluding, Temporary
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 18, 2000 |
| Received | Apr 18, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001237
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.