510(k) DEN250057
- Device
- PCWP Analysis Software
- Applicant
- Cardiosense, Inc.
- 510(k) number
- DEN250057
- Product code
- SIF
- Decision
- Unknown (DENG)
- Decision date
- 2026-05-22
- Date received
- 2025-11-17
- Regulation
- 870.1150
- Classification name
- Software Device System For Estimation Of Cardiac Pressures
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Arezou Azar
- Address
- 400 N Aberdeen St. Suite 1050 Chicago IL US 60642 60642
Source Documents#
510(k) summary PDF not indicated by FDA