510(k) DEN250057
DEN250057 is an FDA 510(k) premarket notification submitted by Cardiosense, Inc. for the device "PCWP Analysis Software". The FDA issued a decision of De Novo Granted on May 22, 2026. The device falls under product code SIF (Software Device System For Estimation Of Cardiac Pressures), a Class II device regulated under 21 CFR 870.1150. Cardiosense, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 22, 2026
- Date Received
- November 17, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software Device System For Estimation Of Cardiac Pressures
- Device Class
- Class II
- Regulation Number
- 870.1150
- Review Panel
- CV
- Submission Type
This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure.