FDA 510(k) Application Details - K142051

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K142051
Device Name	Wire, Guide, Catheter
Applicant	MERIT MEDICAL SYSTEMS INC. PARKMORE BUSINESS PARK WEST GALWAY EI IE Other 510(k) Applications for this Company
Contact	MICHAEL O'SULLIVAN Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2014
Decision Date	12/17/2014
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