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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 K970264
Device Name CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM
Applicant
Cordis Webster, Inc.
4750 Littlejohn St.
Baldwin Park,  CA  91706
Applicant Contact MARY ADAMS
Correspondent
Cordis Webster, Inc.
4750 Littlejohn St.
Baldwin Park,  CA  91706
Correspondent Contact MARY ADAMS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/23/1997
Decision Date 10/28/1997
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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