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FDA 510(k)

Go2Wire Guide Wire

K-Number: K193571 · 2020-04-08

ApplicantMerit Medical System, Inc.
Decision Date2020-04-08
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Go2Wire Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical System, Inc.. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K193571. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Go2Wire Guide Wire?

Go2Wire Guide Wire is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Merit Medical System, Inc.. The 510(k) number is K193571.

When did Go2Wire Guide Wire receive FDA 510(k) clearance?

Go2Wire Guide Wire received FDA 510(k) clearance on 2020-04-08, under 510(k) number K193571.

Who is the listed applicant for Go2Wire Guide Wire?

The FDA 510(k) record lists Merit Medical System, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Go2Wire Guide Wire?

The FDA product code for Go2Wire Guide Wire is DQX.

Other records listing Merit Medical System, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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