K201011 is an FDA 510(k) clearance for the Medtronic Model 5392 External Pulse Generator (EPG). This device is classified as a Pulse-generator, Pacemaker, External (Class II - Special Controls, product code DTE).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on May 13, 2020, 26 days after receiving the submission on April 17, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3600.
| 510(k) Number | K201011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2020 |
| Decision Date | May 13, 2020 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTE — Pulse-generator, Pacemaker, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3600 |