FDA 510(k)

Double Flexible Tip Wire Guides

K-Number: K171912 · 2018-03-19

Decision Date2018-03-19

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Double Flexible Tip Wire Guides is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-03-19 under 510(k) number K171912. 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 Double Flexible Tip Wire Guides?

Double Flexible Tip Wire Guides is a medical device that received FDA 510(k) clearance on 2018-03-19. The listed applicant is Cook Incorporated. The 510(k) number is K171912.

When did Double Flexible Tip Wire Guides receive FDA 510(k) clearance?

Double Flexible Tip Wire Guides received FDA 510(k) clearance on 2018-03-19, under 510(k) number K171912.

Who is the listed applicant for Double Flexible Tip Wire Guides?

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 Double Flexible Tip Wire Guides?

The FDA product code for Double Flexible Tip Wire Guides 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.