510(k) K021066 ยท MJN Catheter, Intravascular Occluding, Temporary
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 18, 2002 |
| Received | Apr 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021066
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.