510(k) K010162 ยท MJN Catheter, Intravascular Occluding, Temporary
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 18, 2001 |
| Received | Jan 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010162
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.