K884215 is an FDA 510(k) clearance for the MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331. 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 November 17, 1988, 42 days after receiving the submission on October 6, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K884215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1988 |
| Decision Date | November 17, 1988 |
| Days to Decision | 42 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 |