FDA 510(k)

MRWire Guide Wire

K-Number: K160594 · 2016-11-22

Decision Date2016-11-22

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MRWire Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Nano4imaging GmbH. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K160594. 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 MRWire Guide Wire?

MRWire Guide Wire is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Nano4imaging GmbH. The 510(k) number is K160594.

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

MRWire Guide Wire received FDA 510(k) clearance on 2016-11-22, under 510(k) number K160594.

Who is the listed applicant for MRWire Guide Wire?

The FDA 510(k) record lists Nano4imaging GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRWire Guide Wire?

The FDA product code for MRWire Guide Wire is DQX.

Other records listing Nano4imaging GmbH 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.

K253262EmeryGlide™ (EG18008901)K173423MR Wire Guide Wire Straight, MR Wire Guide Wire Angled

Related Devices (Code: DQX)

K253667Accoat Guide WireSp Medical A/S K261640Merit 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 Medical K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

Official Source

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