DRN
- Product code
- DRN
- Device name
- Device, Counter-Pulsating, External
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.5225
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 34
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K250756 | 2025-12-22 | Pression, Inc. | Pression Wave PRO External Counter-Pulsation System summary |
Official FDA classification page: DRN
Classification and pathway per current FDA publications. Data from openFDA (CC0).