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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 K252533
Device Name HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
Applicant
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Applicant Contact Niharika Mirji
Correspondent
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Niharika Mirji
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQE   DSB   DXN   FLL   MUD  
QAQ   QEM   QMS   QNL  
Date Received08/12/2025
Decision Date 12/18/2025
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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