FDA 510(k) Application Details - K153384

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K153384
Device Name	System, Perfusion, Kidney
Applicant	United Therapeutics Corporation 55 TW Alexander Drive, PO Box 14186 Research Triangle Park, NC 27709 US Other 510(k) Applications for this Company
Contact	Rita Lee 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	11/23/2015
Decision Date	02/19/2016
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