510(k) K863418 ยท DXY Implantable Pacemaker Pulse-Generator
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
| Applicant | Intermedics, Inc., Freeport TX, US |
| Decision | Substantially Equivalent, Sep 24, 1986 |
| Received | Sep 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863418
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.