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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 K120585
Model H74939228
Device Name CONVEY GUIDING CATHETER
Original Applicant
PENDRACARE INTERNATIONAL, B.V.
7205 laketree dr
raleigh,  NC  27615
Original Contact tom nolan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/27/2012
Decision Date 08/08/2012
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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