K932884 is an FDA 510(k) clearance for the MINIX/MINIX ST PULSE GENERATORS. 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 May 2, 1994, 322 days after receiving the submission on June 14, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K932884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | June 14, 1993 |
| Decision Date | May 02, 1994 |
| Days to Decision | 322 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXY — Implantable Pacemaker Pulse-generator |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3610 |