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FDA 510(k)

Warrior 14 guidewire

K-Number: K180128 · 2018-02-16

ApplicantVascular Solutions, Inc.
Decision Date2018-02-16
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Warrior 14 guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K180128. 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 Warrior 14 guidewire?

Warrior 14 guidewire is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K180128.

When did Warrior 14 guidewire receive FDA 510(k) clearance?

Warrior 14 guidewire received FDA 510(k) clearance on 2018-02-16, under 510(k) number K180128.

Who is the listed applicant for Warrior 14 guidewire?

The FDA 510(k) record lists Vascular Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Warrior 14 guidewire?

The FDA product code for Warrior 14 guidewire 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.

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