FDA 510(k) Application Details - K173414

Device Classification Name	Catheter, Biliary, Surgical   More FDA Info for this Device
510(K) Number	K173414
Device Name	Catheter, Biliary, Surgical
Applicant	Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Colin Jacob Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	GCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2017
Decision Date	06/22/2018
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review