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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 K113459
Device Name ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
Applicant
EDWARDS LIFESCIENCES, LLC.
12050 Lone Peak Pkwy
Draper,  UT  84020
Applicant Contact DANNETTE CROOMS
Correspondent
EDWARDS LIFESCIENCES, LLC.
12050 Lone Peak Pkwy
Draper,  UT  84020
Correspondent Contact DANNETTE CROOMS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/22/2011
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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