INQWIRE DIAGNOSTIC 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 Inqwire Diagnostic Guide Wire.

Pre-market Notification Details

Device IDK133230
510k NumberK133230
Device Name:INQWIRE DIAGNOSTIC GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway,  IE Ei
ContactSiobhan King
CorrespondentSiobhan King
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 Received2013-10-21
Decision Date2013-12-12
Summary:summary

NIH GUDID Devices

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