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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 K060902
Device Name STARCLOSE INTRODUCER SET MODEL- 1002
Applicant
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact KIM SMITH -SERVANCE
Correspondent
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact KIM SMITH -SERVANCE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/03/2006
Decision Date 07/07/2006
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
Recalls CDRH Recalls
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