FDA 510(k) Application Details - K241581

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K241581
Device Name	Catheter, Hemodialysis, Implanted
Applicant	Haolang Medical USA Corporation 1100 Bellevue Way NE 8A-533 Bellevue, WA 98004 US Other 510(k) Applications for this Company
Contact	Lisa Xu 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	06/03/2024
Decision Date	05/16/2025
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