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 a medical device manufactured by Nano4imaging GmbH. It received FDA 510(k) clearance on 2016-11-22 under approval 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. It is manufactured by Nano4imaging GmbH. The 510(k) number is K160594.

When was MRWire Guide Wire approved by the FDA?

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

What company makes MRWire Guide Wire?

MRWire Guide Wire is manufactured by Nano4imaging GmbH.

What is the FDA product code for MRWire Guide Wire?

The FDA product code for MRWire Guide Wire is DQX.

Other Devices by Nano4imaging GmbH

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

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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.