FDA 510(k) Application Details - K974067

Device Classification Name	More FDA Info for this Device
510(K) Number	K974067
Device Name	FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
Applicant	MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	DENNIS REIGLE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/1997
Decision Date	02/27/1998
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