FDA 510(k)

Mandril Wire Guide

K-Number: K171997 · 2018-03-30

Decision Date2018-03-30

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Mandril 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 2018-03-30 under 510(k) number K171997. 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 Mandril Wire Guide?

Mandril Wire Guide is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Cook Incorporated. The 510(k) number is K171997.

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

Mandril Wire Guide received FDA 510(k) clearance on 2018-03-30, under 510(k) number K171997.

Who is the listed applicant for Mandril 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 Mandril Wire Guide?

The FDA product code for Mandril Wire Guide is DQX.

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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.