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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 K050371
Device Name MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
Original Applicant
MEDRAD, INC.
one medrad dr.
indianola,  PA  15051
Original Contact geoff m fatzinger
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/14/2005
Decision Date 06/07/2005
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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