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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K053310
Device Name VASCON ROAMER MICROCATHETER
Applicant
Vascon, LLC
9344 NW 13th St.
Miami,  FL  33172
Applicant Contact STEPHEN F VADAS
Correspondent
Vascon, LLC
9344 NW 13th St.
Miami,  FL  33172
Correspondent Contact STEPHEN F VADAS
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/28/2005
Decision Date 07/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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