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FDA 510(k)

Bandit guidewire

K-Number: K181647 · 2018-07-20

ApplicantVascular Solutions, Inc.
Decision Date2018-07-20
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bandit 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 2018-07-20 under 510(k) number K181647. 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 Bandit guidewire?

Bandit guidewire is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K181647.

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

Bandit guidewire received FDA 510(k) clearance on 2018-07-20, under 510(k) number K181647.

Who is the listed applicant for Bandit 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 Bandit guidewire?

The FDA product code for Bandit guidewire is DQX.

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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.

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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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