510(k) K970388 ยท DTD Pacemaker Lead Adaptor
A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent - Subject to Tracking & PMS, Aug 14, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970388
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.