K250756
- 510(k) number
- K250756
- Device name
- Pression Wave PRO External Counter-Pulsation System
- Applicant
- Pression, Inc. PA · US
- Product code
- DRN — Device, Counter-Pulsating, External
- Decision date
- 2025-12-22
- Date received
- 2025-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250756.pdf
Official FDA record: K250756
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.