510(k) K152633 ยท LDF Electrode, Pacemaker, Temporary
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 15, 2015 |
| Received | Sep 15, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152633
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.