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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 K142136
Device Name ACCUCATH MIDLINE CATHETER SYSTEM
Applicant
Vascular Pathways, Inc.
1847 Trade Center Way
Naples,  FL  34109
Applicant Contact SCOTT PEASE
Correspondent
Vascular Pathways, Inc.
1847 Trade Center Way
Naples,  FL  34109
Correspondent Contact SCOTT PEASE
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/04/2014
Decision Date 01/08/2015
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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