DTE — Pulse-Generator, Pacemaker, External Class II
FDA product code DTE covers "Pulse-Generator, Pacemaker, External", a Class II medical device regulated under 21 CFR 870.3600. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTE
- Device Class
- Class II
- Regulation Number
- 870.3600
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241781 | solo pace | Solo Pace Control | January 10, 2025 |
| K232721 | shenzhen lifetech cardio medical electronics co | Lifetech Cardio Temporary Pacemaker | January 7, 2024 |
| K201011 | medtronic | Medtronic Model 5392 External Pulse Generator (EPG) | May 13, 2020 |
| K190825 | medtronic | Medtronic Model 5392 External Pulse Generator (EPG) | April 30, 2019 |
| K182839 | shenzhen lifetech cardio medical electronics co | Lifetech Cardio Model 8301 Temporary Pacemaker | February 28, 2019 |
| K181973 | medtronic | Medtronic Model 5392 External Pulse Generator (EPG) | August 21, 2018 |
| K180873 | medtronic | Medtronic Model 53401 External Pulse Generator (EPG) | April 19, 2018 |
| K162054 | medtronic | Medtronic Temporary External Pacemaker 53401 | October 18, 2016 |
| K162550 | medtronic | Medtronic Model 5392 External Pulse Generator (EPG) | October 12, 2016 |
| K150246 | medtronic | Medtronic Model 5392 External Pulse Generator (EPG) | February 18, 2015 |
| K132924 | medtronic | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) | October 31, 2013 |
| K123916 | osypka medical | PSA SERIES | April 9, 2013 |
| K042708 | biotronik | ERA 3000 PACING SYSTEM ANALYZER | October 20, 2004 |
| K033130 | osypka medical | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | October 31, 2003 |
| K023080 | galix biomedical instrumentation | GALIX PACESTAR | June 11, 2003 |
| K022939 | osypka medical | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES, | October 3, 2002 |
| K020896 | osypka medical | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MOD | June 14, 2002 |
| K011980 | pace medical | ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 | September 12, 2001 |
| K002204 | pace medical | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V | October 18, 2000 |
| K001180 | pace medical | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMA | June 27, 2000 |