510(k) K011526 ยท MJN Catheter, Intravascular Occluding, Temporary
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 14, 2001 |
| Received | May 17, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011526
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.