510(k) K011656 ยท MJN Catheter, Intravascular Occluding, Temporary
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 20, 2001 |
| Received | May 29, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011656
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.