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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K110103
Device Name EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
Applicant
EDWARDS LIFESCIENCES LLC
12050 LONE PEAK PARKWAY
DRAPER,  UT  84020 -0000
Applicant Contact SPENCER WALKER
Correspondent
EDWARDS LIFESCIENCES LLC
12050 LONE PEAK PARKWAY
DRAPER,  UT  84020 -0000
Correspondent Contact SPENCER WALKER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/13/2011
Decision Date 02/11/2011
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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