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FDA 510(k)

Spectre guidewire

K-Number: K163444 · 2017-01-06

ApplicantVascular Solutions, Inc.
Decision Date2017-01-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Spectre 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 2017-01-06 under 510(k) number K163444. 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 Spectre guidewire?

Spectre guidewire is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K163444.

When did Spectre guidewire receive FDA 510(k) clearance?

Spectre guidewire received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163444.

Who is the listed applicant for Spectre 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 Spectre guidewire?

The FDA product code for Spectre 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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