K232261 is an FDA 510(k) clearance for the TME Temporary Myocardial Electrode. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Osypka AG (Rheinfelden, DE). The FDA issued a Cleared decision on April 26, 2024, 270 days after receiving the submission on July 31, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K232261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2023 |
| Decision Date | April 26, 2024 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDF - Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |