510(k) K953044 ยท DTB Permanent Pacemaker Electrode
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent - Subject to Tracking & PMS, Sep 27, 1996 |
| Received | Jun 30, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953044
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.