FDA 510(k) Application Details - K053171

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K053171
Device Name	Catheter, Intravascular, Diagnostic
Applicant	MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	STEPHANIE ERSKINE 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	11/14/2005
Decision Date	01/19/2006
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	Y
Expedited Review