FDA 510(k) Application Details - K243870

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K243870
Device Name	System, Perfusion, Kidney
Applicant	Traferox Technologies Inc. 3505, Laird Rd. Unit 16 Mississauga L5L 5Y7 CA Other 510(k) Applications for this Company
Contact	Anuradha Iyer Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	KDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2024
Decision Date	05/01/2025
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