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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 K031583
Device Name MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
Applicant
Integrated Vascular Systems, Inc.
743 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact SUSAN TURNER
Correspondent
Integrated Vascular Systems, Inc.
743 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact SUSAN TURNER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/21/2003
Decision Date 06/16/2003
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
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