MERIT HYDROPHILIC GUIDE WIRE

Wire, Guide, Catheter

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Hydrophilic Guide Wire.

Pre-market Notification Details

Device IDK131710
510k NumberK131710
Device Name:MERIT HYDROPHILIC GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway,  IE Ei
ContactMartha Folan
CorrespondentMartha Folan
MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway,  IE Ei
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-11
Decision Date2013-07-29
Summary:summary

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