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 IDK002289
510k NumberK002289
Device Name:INQWIRE DIAGNOSTIC GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactChester Mccoy
CorrespondentChester Mccoy
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-27
Decision Date2000-10-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884450094604 K002289 000
10884450094478 K002289 000
10884450085315 K002289 000
10884450056537 K002289 000

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