FDA 510(k) Application Details - K172592

Device Classification Name	More FDA Info for this Device
510(K) Number	K172592
Device Name	CADD Yellow High Volume Administration Set with NRFit connector
Applicant	Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 US Other 510(k) Applications for this Company
Contact	Michael R. Johnson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2017
Decision Date	05/17/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review