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510(k) K173414

Advance Biliary Balloon Catheter by Cook Incorporated — Product Code GCA

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 22, 2018
Date Received
November 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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