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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 K120229
Model VARIOUS CATALOG NUMBERS
Device Name ENVOY DISTAL ACCESS GUIDING CATHETER
Original Applicant
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham,  MA  02767 0350
Original Contact catherine kilshaw
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/25/2012
Decision Date 02/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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