PCWP Analysis Software— 510(k) DEN250057

Unknown

Cardiosense, Inc.

FDA 510(k) clearance DEN250057 for PCWP Analysis Software, Unknown on 2026-05-22. Applicant: Cardiosense, Inc..

Clearance details

Applicant: Cardiosense, Inc.
Product code: Code SIF
Advisory panel: Cardiovascular
Date received: 2025-11-17
Decision date: 2026-05-22
Decision: Unknown
Clearance type: Direct
Location: Chicago, IL, US

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