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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K062554
Device Name STARCLOSE HEX-HUB DILATOR
Applicant
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact Daun Putnam
Correspondent
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact Daun Putnam
Regulation Number870.1310
Classification Product Code
DRE  
Date Received08/30/2006
Decision Date 02/06/2007
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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