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FDA 510(k)

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

K-Number: K212167 · 2022-02-09

ApplicantVascular Solutions, LLC
Decision Date2022-02-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is a medical device manufactured by Vascular Solutions, LLC. It received FDA 510(k) clearance on 2022-02-09 under approval 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. It is manufactured by Vascular Solutions, LLC. The 510(k) number is K212167.

When was R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire approved by the FDA?

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

What company makes R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire?

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is manufactured by Vascular Solutions, LLC.

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.

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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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