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FDA 510(k)

Spectre guidewire

K-Number: K163444 · 2017-01-06

ApplicantVascular Solutions, Inc.
Decision Date2017-01-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Spectre guidewire is a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-01-06 under approval number K163444. 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 Spectre guidewire?

Spectre guidewire is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K163444.

When was Spectre guidewire approved by the FDA?

Spectre guidewire received FDA 510(k) clearance on 2017-01-06, under approval number K163444.

What company makes Spectre guidewire?

Spectre guidewire is manufactured by Vascular Solutions, Inc..

What is the FDA product code for Spectre guidewire?

The FDA product code for Spectre 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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