510(k) K003320 ยท MJN Catheter, Intravascular Occluding, Temporary
PTA-OS SIZING BALLOON, MODEL 360
| Applicant | NuMED, Inc., Hopkinton NY, US |
| Decision | Substantially Equivalent, May 2, 2001 |
| Received | Oct 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003320
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.