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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K233819
Device Name Fogarty Venous Thrombectomy Catheters
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Unji Lee
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Unji Lee
Regulation Number870.5150
Classification Product Code
DXE  
Date Received12/01/2023
Decision Date 05/22/2024
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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