510(k) K011557 ยท DXF Catheter, Septostomy
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
| Applicant | NuMED, Inc., Hopkinton NY, US |
| Decision | Substantially Equivalent, Jul 12, 2001 |
| Received | May 21, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011557
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.