FDA 510(k) Application Details - K122937

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K122937
Device Name	Catheter, Intravascular, Diagnostic
Applicant	COOK, INC. 750 DANIELS WAY Blmgtn, IN 47404 US Other 510(k) Applications for this Company
Contact	AMBER BROWN 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	09/24/2012
Decision Date	12/14/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review