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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K253576
Device Name CorVista System® with PCWP Add-On
Applicant
Analytics For Life, Inc.
3 Bethesda Metro Center
Suite 700
Bethesda,  MD  20814
Applicant Contact Stephen Davies
Correspondent
Analytics For Life, Inc.
3 Bethesda Metro Center
Suite 700
Bethesda,  MD  20814
Correspondent Contact Stephen Davies
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/17/2025
Decision Date 07/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT03864081
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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