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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 K112554
Model MULTIPLE; EX. AA-10507-1
Device Name TRANSRADIAL ARTERY ACCESS DEVICES
Original Applicant
TELEFLEX MEDICAL, INC.
2400 bernville road
reading,  PA  19605
Original Contact christine ford
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/02/2011
Decision Date 11/18/2011
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
Recalls CDRH Recalls
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