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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K071778
Device Name HERO VASCULAR ACCESS DEVICE
Applicant
Graftcath, Inc.
6545 City W. Pkwy.
Eden Prarie,  MN  55344
Applicant Contact LAURIE LYNCH
Correspondent
Graftcath, Inc.
6545 City W. Pkwy.
Eden Prarie,  MN  55344
Correspondent Contact LAURIE LYNCH
Regulation Number870.3450
Classification Product Code
DSY  
Subsequent Product Codes
LJS   MSD  
Date Received07/02/2007
Decision Date 01/30/2008
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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