K901535 is an FDA 510(k) clearance for the MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.. This device is classified as a Implantable Pacemaker Pulse-generator (Class III - Premarket Approval, product code DXY).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 3, 1990, 92 days after receiving the submission on April 2, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K901535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1990 |
| Decision Date | July 03, 1990 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXY — Implantable Pacemaker Pulse-generator |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3610 |