510(k) K955550 ยท DTB Permanent Pacemaker Electrode
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
| Applicant | Intermedics, Inc., Angleton TX, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jun 19, 1996 |
| Received | Dec 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955550
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.