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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 K962746
Device Name CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
Applicant
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact MARLENE W VALENTI
Correspondent
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact MARLENE W VALENTI
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/15/1996
Decision Date 10/11/1996
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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