FDA 510(k) Application Details - K122940

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K122940
Device Name	Catheter, Percutaneous
Applicant	COOK, INC. 750 DANIELS WAY Blmgtn, IN 47404 US Other 510(k) Applications for this Company
Contact	ELYSIA EASTON Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2012
Decision Date	03/19/2013
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