FDA 510(k) Application Details - K192375

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K192375
Device Name	Set, Administration, Intravascular
Applicant	Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 US Other 510(k) Applications for this Company
Contact	Wendy Hills Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2019
Decision Date	09/18/2020
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