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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 a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2018-07-20 under approval 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. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K181647.

When was Bandit guidewire approved by the FDA?

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

What company makes Bandit guidewire?

Bandit guidewire is manufactured by Vascular Solutions, Inc..

What is the FDA product code for Bandit guidewire?

The FDA product code for Bandit guidewire is DQX.

Other Devices by Vascular Solutions, Inc.

K161702Endura guidewire K162272Fluent inflation device K161336VSI StraitSet micro-introducer kit K173532Raider Guidewire K173266Octane aspiration system K170544Langston dual lumen catheter

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Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

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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