510(k) K853425 ยท DXY Implantable Pacemaker Pulse-Generator
CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR
| Applicant | Cardio-Pace Medical, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 19, 1985 |
| Received | Aug 14, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853425
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.