FDA 510(k) Application Details - K183219

Device Classification Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted   More FDA Info for this Device
510(K) Number	K183219
Device Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Applicant	Medical Components Inc. (dba MedComp) 1499 Delp Drive Harleysville, PA 19438 US Other 510(k) Applications for this Company
Contact	Courtney Nix Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	NIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2018
Decision Date	06/14/2019
Decision	SEKD - SUBST EQUIV - KIT WITH DRUGS
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