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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K081878
Device Name LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
Original Applicant
LEMAITRE VASCULAR, INC.
63 second avenue
burlington,  MA  01803
Original Contact erin daly
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/02/2008
Decision Date 01/27/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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