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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K121185
Model INTROPA
Device Name EDWARDS PERCUTANEOUS SHEATH INTRODUCER
Original Applicant
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy.
draper,  UT  84020
Original Contact spencer walker
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/23/2012
Decision Date 08/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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