FDA 510(k) Application Details - K153158

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K153158
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	11/02/2015
Decision Date	12/28/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review