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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K130730
Device Name V-STICK VASCULAR ACCESS SET
Applicant
Argon Medical
3600 S.W 47th Ave.
Gainesville,  FL  32608
Applicant Contact JENNIFER BONACCI
Correspondent
Argon Medical
3600 S.W 47th Ave.
Gainesville,  FL  32608
Correspondent Contact JENNIFER BONACCI
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/18/2013
Decision Date 11/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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