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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K140608
Device Name MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
Applicant
MERIT MEDICAL SYSTEMS, INC.
PARKMORE BUSINESS PARK WEST
GALWAY,  IE EI
Applicant Contact SIOBHAN KING
Correspondent
MERIT MEDICAL SYSTEMS, INC.
PARKMORE BUSINESS PARK WEST
GALWAY,  IE EI
Correspondent Contact SIOBHAN KING
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/10/2014
Decision Date 09/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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