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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K113819
Device Name MONGOOSE ANGIOGRAPHIC CATHETER
Original Applicant
PEDIACATH INC.
611 west 5th street
austin,  TX  78701
Original Contact caroline tontini
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/27/2011
Decision Date 07/11/2012
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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