510(k) K110103 ยท DQO Catheter, Intravascular, Diagnostic
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Feb 11, 2011 |
| Received | Jan 13, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110103
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.