DEN250057
- 510(k) number
- DEN250057
- Device name
- PCWP Analysis Software
- Applicant
- Cardiosense, Inc. IL · US
- Product code
- SIF — Software Device System For Estimation Of Cardiac Pre
- Decision date
- 2026-05-22
- Date received
- 2025-11-17
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN250057
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.