FDA 510(k) Application Details - K162448

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K162448
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Cook Incorporated 750 Daniels Way Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Jessica Swafford Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2016
Decision Date	05/26/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review