K232721 is an FDA 510(k) clearance for the Lifetech Cardio Temporary Pacemaker. This device is classified as a Pulse-generator, Pacemaker, External (Class II - Special Controls, product code DTE).
Submitted by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2024, 124 days after receiving the submission on September 5, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3600.
| 510(k) Number | K232721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2023 |
| Decision Date | January 07, 2024 |
| Days to Decision | 124 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 |