510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250057Unknown

PCWP Analysis Software

Cardiosense, Inc., Chicago IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN250057 is the FDA 510(k) clearance record for PCWP Analysis Software, a class II device, cleared for Cardiosense, Inc. on under FDA product code SIF (Software Device System For Estimation Of Cardiac Pressures). FDA's definition for product code SIF reads: "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...". FDA records list 2 510(k) clearances for Cardiosense, Inc., from to . As of , FDA records show no recalls naming DEN250057.

Clearance record

Decision date
Received
(186 days to decision)
Product code
SIF Software Device System For Estimation Of Cardiac Pressures
Regulation
21 CFR 870.1150
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiosense, Inc. 400 N Aberdeen St., Chicago IL
Third party review
No

Clearances, product code SIF

Trailing 12 months
1 clearance under product code SIF in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260