FDA 510(k) Application Details - K141322

Device Classification Name	More FDA Info for this Device
510(K) Number	K141322
Device Name	ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
Applicant	COOK INCORPORATED 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON, IN 47402 US Other 510(k) Applications for this Company
Contact	STEVEN LAWRIE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2014
Decision Date	03/27/2015
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