Clearance Summary
PCWP Analysis Software received FDA 510(k) clearance under submission number DEN250057, sponsored by Cardiosense, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-05-22.
- Submission: DEN250057
- Applicant / Sponsor: Cardiosense, Inc.
- Clearance pathway: Direct
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1150
- Decision date: 2026-05-22
Classification & Regulation
This clearance is catalogued under FDA product code SIF and 21 CFR 870.1150, within the Cardiovascular review panel as a Class II device.