Lifetech Cardio Temporary Pacemaker
FDA 510(k) clearance K232721 · decided 2024-01-07
Clearance details
- K-number
- K232721
- Device name
- Lifetech Cardio Temporary Pacemaker
- Applicant
- Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-05
- Decision date
- 2024-01-07
- Days to decision
- 124 days
- Clearance type
- Special
- Product code
- DTE
- Device class
- 2
- Regulation number
- 870.3600
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Solo Pace Control (K241781) | Solo Pace, Inc. | 2025-01-10 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K201011) | Medtronic, Inc. | 2020-05-13 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K190825) | Medtronic, Inc. | 2019-04-30 |
| Lifetech Cardio Model 8301 Temporary Pacemaker (K182839) | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019-02-28 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K181973) | Medtronic, Inc. | 2018-08-21 |
| Medtronic Model 53401 External Pulse Generator (EPG) (K180873) | Medtronic, Inc. | 2018-04-19 |
| Medtronic Temporary External Pacemaker 53401 (K162054) | Medtronic, Inc. | 2016-10-18 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K162550) | Medtronic, Inc. | 2016-10-12 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K150246) | Medtronic, Inc. | 2015-02-18 |
| MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (K132924) | Medtronic, Inc. | 2013-10-31 |
| PSA SERIES (K123916) | Osypka Medical, Inc. | 2013-04-09 |
| ERA 3000 PACING SYSTEM ANALYZER (K042708) | Biotronik, Inc. | 2004-10-20 |
Recalls involving this device
No recalls on record reference this clearance.