FDA 510(k) Application Details - K173805

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K173805
Device Name	Catheter, Hemodialysis, Implanted
Applicant	Marvao Medical Devices, Ltd. GMIT Innovation in Business Centre, Dublin Road Galway H91 DCH9 IE Other 510(k) Applications for this Company
Contact	Christopher Davey Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2017
Decision Date	02/08/2018
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