510(k) K901535 ยท DXY Implantable Pacemaker Pulse-Generator
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
| Applicant | Medtronic Vascular, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 3, 1990 |
| Received | Apr 2, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901535
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.