FDA 510(k) Application Details - K234060

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K234060
Device Name	System, Perfusion, Kidney
Applicant	Paragonix Technologies 950 Winter St Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Lucas Churchill 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	12/22/2023
Decision Date	10/23/2024
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