510(k) K063293 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE
| Applicant | Edwards Lifesciences Services GmbH, Stevenage, GB |
| Decision | Substantially Equivalent, Mar 23, 2007 |
| Received | Nov 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063293
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.