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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 K052004
Device Name VASCON NEUROPATH GUIDING CATHETER
Original Applicant
VASCON LLC
4613 n. university drive
suite 300
coral springs,  FL  33067
Original Contact roberta d goode
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/25/2005
Decision Date 01/19/2006
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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