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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Thrombolysis Catheter
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
Applicant Contact DENNIS REIGLE
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN,  UT  84095
Correspondent Contact DENNIS REIGLE
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received10/27/1997
Decision Date 02/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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