510(k) K870562 ยท DTD Pacemaker Lead Adaptor
DAIG PACEMAKER LEAD ADAPTOR
| Applicant | Daig Corp., Minnetonka MN, US |
| Decision | Substantially Equivalent, Mar 3, 1987 |
| Received | Feb 10, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870562
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2009 | Greatbatch Medical Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. Terminated |
DTB | None listed |
| Nov 9, 2006 | Enpath Medical, Inc Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Terminated |
DTB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.