FDA 510(k) Application Details - K192366

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K192366
Device Name	Set, Administration, Intravascular
Applicant	Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 US Other 510(k) Applications for this Company
Contact	Gary Chumbimune 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	07/20/2020
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