Go2Wire Guide Wire

Wire, Guide, Catheter

Merit Medical System, Inc.

The following data is part of a premarket notification filed by Merit Medical System, Inc. with the FDA for Go2wire Guide Wire.

Pre-market Notification Details

Device IDK193571
510k NumberK193571
Device Name:Go2Wire Guide Wire
ClassificationWire, Guide, Catheter
Applicant Merit Medical System, Inc. Parkmore Business Park West Galway,  IE
ContactMark Mullaney
CorrespondentMichael O'sullivan
Merit Medical System, Inc. Parkmore Business Park West Galway,  IE
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2020-04-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884450372238 K193571 000
20884450397453 K193571 000
20884450372306 K193571 000
10884450397449 K193571 000
10884450372224 K193571 000
20884450397330 K193571 000
10884450372101 K193571 000
20884450372276 K193571 000
20884450372269 K193571 000
10884450372293 K193571 000
20884450397354 K193571 000
10884450397463 K193571 000
10884450372248 K193571 000
10884450372217 K193571 000
10884450397364 K193571 000
10884450397425 K193571 000
10884450397340 K193571 000

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