FDA 510(k) Application Details - K211333

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K211333
Device Name	System, Perfusion, Kidney
Applicant	XVIVO Perfusion AB MΣssans Gata 10 Goteborg 41251 SE Other 510(k) Applications for this Company
Contact	Arjan van der Plaats 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	05/03/2021
Decision Date	01/20/2022
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