DTE
- Product code
- DTE
- Device name
- Pulse-Generator, Pacemaker, External
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.3600
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 65 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241781 | 2025-01-10 | Solo Pace, Inc. | Solo Pace Control | |
| K232721 | 2024-01-07 | Shenzhen Lifetech Cardio Medical Elect… | Lifetech Cardio Temporary Pacemaker |
Official FDA classification page: DTE
Classification and pathway per current FDA publications. Data from openFDA (CC0).