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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 K140208
Device Name FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
Applicant
EDWARDS LIFESCIENCES, LLC.
12050 Lone Peak Pkwy
Draper,  UT  84020
Applicant Contact LINDSAY MARTIN
Correspondent
EDWARDS LIFESCIENCES, LLC.
12050 Lone Peak Pkwy
Draper,  UT  84020
Correspondent Contact LINDSAY MARTIN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/28/2014
Decision Date 03/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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