510(k) K052564 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
VYGON LEADER-FLEX
| Applicant | Vygon Corp., Norristown PA, US |
| Decision | Substantially Equivalent, Apr 5, 2006 |
| Received | Sep 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052564
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.