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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 K043387
Device Name VASCON POLARIS GUIDING CATHETER
Original Applicant
VASCON LLC
9344 nw 13th street
miami,  FL  33172
Original Contact stephen f vadas
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/09/2004
Decision Date 02/16/2005
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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