FDA 510(k) Application Details - K243607

Device Classification Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve   More FDA Info for this Device
510(K) Number	K243607
Device Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant	Diality, Inc. 181 Technology Drive Suite 150 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Clayton Poppe Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2024
Decision Date	12/20/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review