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510(k) K180081

RAILWAY Sheathless Access System by Cordis Corporation — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2018
Date Received
January 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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