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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K200358
Device Name Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
Applicant
Edwards Lifesciences LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Anna Califato
Correspondent
Edwards Lifesciences LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Anna Califato
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/13/2020
Decision Date 03/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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