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FDA 510(k)

Worker Guidewire

K-Number: K160785 · 2016-12-08

ApplicantArgon Medical Devices, Inc.
Decision Date2016-12-08
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Worker Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K160785. 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 Worker Guidewire?

Worker Guidewire is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K160785.

When did Worker Guidewire receive FDA 510(k) clearance?

Worker Guidewire received FDA 510(k) clearance on 2016-12-08, under 510(k) number K160785.

Who is the listed applicant for Worker Guidewire?

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

What is the FDA product code for Worker Guidewire?

The FDA product code for Worker Guidewire 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.

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