510(k) K101570 ยท MJN Catheter, Intravascular Occluding, Temporary
HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS
| Applicant | Micro Therapeutics Dba Ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 13, 2010 |
| Received | Jun 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101570
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.