FDA 510(k) Application Details - K243505

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K243505
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Laura Reed Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	KDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2024
Decision Date	05/30/2025
Decision	SESE - SUBST EQUIV
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