K953866 is an FDA 510(k) clearance for the MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION). 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 December 15, 1995, 127 days after receiving the submission on August 10, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K953866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | August 10, 1995 |
| Decision Date | December 15, 1995 |
| Days to Decision | 127 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 |