FDA 510(k) Application Details - K161496

Device Classification Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days   More FDA Info for this Device
510(K) Number	K161496
Device Name	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant	COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	Steven Lawrie Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	LJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2016
Decision Date	10/07/2016
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