K241199 is an FDA 510(k) clearance for the Rotatable Connector (5944RL). This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Shenzhen Launch Electrical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 23, 2025, 268 days after receiving the submission on April 30, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K241199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2024 |
| Decision Date | January 23, 2025 |
| Days to Decision | 268 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 |