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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K242451
Device Name HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
Applicant
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Applicant Contact Varad Raghuwanshi
Correspondent
Edwards Lifesciences
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Varad Raghuwanshi
Regulation Number870.1240
Classification Product Code
DYG  
Subsequent Product Codes
DQE   DSB   DXN   FLL   MUD  
QAQ   QEM   QMS   QNL  
Date Received08/16/2024
Decision Date 12/09/2024
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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