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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 K180081
Device Name RAILWAY Sheathless Access System
Applicant
Cordis Corporation
1820 McCarthy Boulevard
Milpitas,  CA  95035
Applicant Contact Michelle Ragozzino Rodgers
Correspondent
Cordis Corporation
1820 McCarthy Boulevard
Milpitas,  CA  95035
Correspondent Contact Ankita Phophalia
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/11/2018
Decision Date 04/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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