510(k) K030630 ยท DQY Catheter, Percutaneous
EDWARDS DIRECTIONAL CATHETER
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 3, 2003 |
| Received | Feb 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030630
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.