FDA 510(k)

Fixed Core Wire Guides

K-Number: K171764 · 2018-03-09

Decision Date2018-03-09

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Fixed Core 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 2018-03-09 under 510(k) number K171764. 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 Fixed Core Wire Guides?

Fixed Core Wire Guides is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Cook Incorporated. The 510(k) number is K171764.

When did Fixed Core Wire Guides receive FDA 510(k) clearance?

Fixed Core Wire Guides received FDA 510(k) clearance on 2018-03-09, under 510(k) number K171764.

Who is the listed applicant for Fixed Core 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 Fixed Core Wire Guides?

The FDA product code for Fixed Core Wire Guides 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.