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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 K193379
Device Name Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Wendy Vera Gonzalez
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Wendy Vera Gonzalez
Regulation Number870.5150
Classification Product Code
DXE  
Subsequent Product Code
GCA  
Date Received12/05/2019
Decision Date 06/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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