FDA 510(k)

Reuter Tip Deflecting Wire Guide

K-Number: K180830 · 2018-12-20

Decision Date2018-12-20

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Reuter Tip Deflecting Wire Guide is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-12-20 under approval number K180830. 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 Reuter Tip Deflecting Wire Guide?

Reuter Tip Deflecting Wire Guide is a medical device that received FDA 510(k) clearance on 2018-12-20. It is manufactured by Cook Incorporated. The 510(k) number is K180830.

When was Reuter Tip Deflecting Wire Guide approved by the FDA?

Reuter Tip Deflecting Wire Guide received FDA 510(k) clearance on 2018-12-20, under approval number K180830.

What company makes Reuter Tip Deflecting Wire Guide?

Reuter Tip Deflecting Wire Guide is manufactured by Cook Incorporated.

What is the FDA product code for Reuter Tip Deflecting Wire Guide?

The FDA product code for Reuter Tip Deflecting Wire Guide is DQX.

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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.