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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 K202167
Device Name Brite Tip Radianz Guiding Sheath
Applicant
Cordis Corporation
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact Crystal Placona
Correspondent
Cordis Corporation
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact Crystal Placona
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/03/2020
Decision Date 02/26/2021
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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