FDA 510(k)

Roadrunner Extra Support Wire Guide

K-Number: K183467 · 2019-01-11

Decision Date2019-01-11

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Roadrunner Extra Support Wire Guide is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K183467. 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 Roadrunner Extra Support Wire Guide?

Roadrunner Extra Support Wire Guide is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Cook Incorporated. The 510(k) number is K183467.

When did Roadrunner Extra Support Wire Guide receive FDA 510(k) clearance?

Roadrunner Extra Support Wire Guide received FDA 510(k) clearance on 2019-01-11, under 510(k) number K183467.

Who is the listed applicant for Roadrunner Extra Support Wire Guide?

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

What is the FDA product code for Roadrunner Extra Support Wire Guide?

The FDA product code for Roadrunner Extra Support Wire Guide is DQX.

Other records listing Cook Incorporated as applicant

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Related Devices (Code: 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.