K861368 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR. This device is classified as a Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (Class II - Special Controls, product code JOQ).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 4, 1986, 115 days after receiving the submission on April 11, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1750.
| 510(k) Number | K861368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1986 |
| Decision Date | August 04, 1986 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | JOQ — Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1750 |