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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Predictive Cardiovascular Indicator
510(k) Number K242518
Device Name Hypertension Prediction Index (HePI) Algorithm
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Daphney Germain-Kolawole
Correspondent
Edwards Lifesciences, LLC
17200 Laguna Canyon Rd.
Irvine,  CA  92602
Correspondent Contact Chirag Shah
Regulation Number870.2210
Classification Product Code
QAQ  
Subsequent Product Codes
DQK   DSB   DXN  
Date Received08/23/2024
Decision Date 05/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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