FDA 510(k) Application Details - K163001

Device Classification Name	More FDA Info for this Device
510(K) Number	K163001
Device Name	PowerFlow Apheresis I.V. Port
Applicant	C.R. BARD, INC. 605 NORTH 5600 WEST SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	Christoph Wagner von Hoff Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2016
Decision Date	04/17/2017
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