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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, vascular
510(k) Number K132175
Device Name EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
Applicant
EDWARDS LIFESCIENCES, LLC.
12050 Lone Peak Pkwy
Draper,  UT  84020
Applicant Contact LUKE MEIDELL
Correspondent
EDWARDS LIFESCIENCES, LLC.
12050 Lone Peak Pkwy
Draper,  UT  84020
Correspondent Contact LUKE MEIDELL
Regulation Number870.4450
Classification Product Code
DXC  
Date Received07/15/2013
Decision Date 09/13/2013
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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