510(k) K964604 ยท DTB Permanent Pacemaker Electrode
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent - Subject to Tracking & PMS, Mar 10, 1997 |
| Received | Nov 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964604
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.