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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 K033633
Device Name VASCON POLARIS GUIDING CATHETER
Applicant
VASCON LLC
9344 NW 13 STREET
MIAMI,  FL  33172
Applicant Contact STEPHEN F VADAS
Correspondent
VASCON LLC
9344 NW 13 STREET
MIAMI,  FL  33172
Correspondent Contact STEPHEN F VADAS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/19/2003
Decision Date 02/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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