FDA 510(k)

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire

K-Number: K212167 · 2022-02-09

Decision Date2022-02-09

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K212167. 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 R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K212167.

When did R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire receive FDA 510(k) clearance?

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire received FDA 510(k) clearance on 2022-02-09, under 510(k) number K212167.

Who is the listed applicant for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

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

What is the FDA product code for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

The FDA product code for R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is DQX.

Other records listing Vascular Solutions, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.