FDA 510(k)

Firebow Wire Torque Assist Device

K-Number: K170684 · 2017-06-29

Decision Date2017-06-29

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Firebow Wire Torque Assist Device is a medical device manufactured by Vesatek, LLC. It received FDA 510(k) clearance on 2017-06-29 under approval number K170684. 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 Firebow Wire Torque Assist Device?

Firebow Wire Torque Assist Device is a medical device that received FDA 510(k) clearance on 2017-06-29. It is manufactured by Vesatek, LLC. The 510(k) number is K170684.

When was Firebow Wire Torque Assist Device approved by the FDA?

Firebow Wire Torque Assist Device received FDA 510(k) clearance on 2017-06-29, under approval number K170684.

What company makes Firebow Wire Torque Assist Device?

Firebow Wire Torque Assist Device is manufactured by Vesatek, LLC.

What is the FDA product code for Firebow Wire Torque Assist Device?

The FDA product code for Firebow Wire Torque Assist Device is DQX.

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Related PubMed Literature

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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.