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FDA 510(k)

Raider Guidewire

K-Number: K173532 · 2017-12-15

Decision Date2017-12-15
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Raider 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 2017-12-15 under 510(k) number K173532. 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 Raider Guidewire?

Raider Guidewire is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K173532.

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

Raider Guidewire received FDA 510(k) clearance on 2017-12-15, under 510(k) number K173532.

Who is the listed applicant for Raider 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 Raider Guidewire?

The FDA product code for Raider Guidewire is DQX.

Other records listing Vascular Solutions, Inc. 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.

View all 32 devices →

Related Devices (Code: DQX)

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.

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.