FDA 510(k) Application Details - K243264

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K243264
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	Sorin Group Italia S.r.l. Via Statale 12 Nord, 86 Mirandola ( Modena) 41037 IT Other 510(k) Applications for this Company
Contact	Martina Carlini 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	10/15/2024
Decision Date	04/25/2025
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