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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name software device system for estimation of cardiac pressures
De Novo Number DEN250057
Device Name PCWP Analysis Software
Requester
cardiosense, inc.
400 n aberdeen st.
suite 1050
chicago,  IL  60642
Contact arezou azar
Regulation Number870.1150
Classification Product Code
SIF  
Date Received11/17/2025
Decision Date 05/22/2026
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 Yes
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