PCWP Analysis Software— 510(k) DEN250057
UnknownCardiosense, Inc.
FDA 510(k) clearance DEN250057 for PCWP Analysis Software, Unknown on 2026-05-22. Applicant: Cardiosense, Inc.. Device class: 2.
Summary
PCWP Analysis Software is from Cardiosense, filed under SIF, software device systems for estimation of cardiac pressures. The record doesn't expand "PCWP".
Class II, 21 CFR 870.1150. Cardiovascular is both the classification panel and the review panel. The record lists the submission type as Direct.
Cardiosense filed from Chicago, Illinois. The decision date came 186 calendar days after the received date (November 17, 2025 to May 22, 2026).
Clearance details
- Applicant
- Cardiosense, Inc.
- Product code
- Product code SIF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Chicago, IL, US
More clearances from Cardiosense, Inc.
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