510(k) K250756 ยท DRN Device, Counter-Pulsating, External
Pression Wave PRO External Counter-Pulsation System
| Applicant | Pression, Inc., Coatesville PA, US |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Mar 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250756
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.