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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K140504
Device Name ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
Applicant
Vascular Pathways, Inc.
1847 Trade Center Way
Naples,  FL  34109
Applicant Contact BILL BOLD
Correspondent
Vascular Pathways, Inc.
1847 Trade Center Way
Naples,  FL  34109
Correspondent Contact BILL BOLD
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/27/2014
Decision Date 07/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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