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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
Applicant
VASCON LLC
4613 N. UNIVERSITY DRIVE
SUITE 300
CORAL SPRINGS,  FL  33067
Applicant Contact ROBERTA D GOODE
Correspondent
VASCON LLC
4613 N. UNIVERSITY DRIVE
SUITE 300
CORAL SPRINGS,  FL  33067
Correspondent Contact ROBERTA D GOODE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/25/2005
Decision Date 01/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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