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FDA 510(k)

Lunderquist® Fixed Core Wire Guide

K-Number: K181353 · 2019-02-15

Decision Date2019-02-15
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lunderquist® Fixed Core Wire Guide is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-02-15 under approval number K181353. 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 Lunderquist® Fixed Core Wire Guide?

Lunderquist® Fixed Core Wire Guide is a medical device that received FDA 510(k) clearance on 2019-02-15. It is manufactured by Cook Incorporated. The 510(k) number is K181353.

When was Lunderquist® Fixed Core Wire Guide approved by the FDA?

Lunderquist® Fixed Core Wire Guide received FDA 510(k) clearance on 2019-02-15, under approval number K181353.

What company makes Lunderquist® Fixed Core Wire Guide?

Lunderquist® Fixed Core Wire Guide is manufactured by Cook Incorporated.

What is the FDA product code for Lunderquist® Fixed Core Wire Guide?

The FDA product code for Lunderquist® Fixed Core Wire Guide is DQX.

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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.