510(k) K113565 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 18, 2012 |
| Received | Dec 2, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113565
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.