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FDA 510(k)

Traxcess 7 Mini Guidewire

K-Number: K201487 · 2020-07-02

ApplicantMicroVention, Inc.
Decision Date2020-07-02
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Traxcess 7 Mini Guidewire is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2020-07-02 under approval number K201487. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Traxcess 7 Mini Guidewire?

Traxcess 7 Mini Guidewire is a medical device that received FDA 510(k) clearance on 2020-07-02. It is manufactured by MicroVention, Inc.. The 510(k) number is K201487.

When was Traxcess 7 Mini Guidewire approved by the FDA?

Traxcess 7 Mini Guidewire received FDA 510(k) clearance on 2020-07-02, under approval number K201487.

What company makes Traxcess 7 Mini Guidewire?

Traxcess 7 Mini Guidewire is manufactured by MicroVention, Inc..

What is the FDA product code for Traxcess 7 Mini Guidewire?

The FDA product code for Traxcess 7 Mini Guidewire is MOF.

Other Devices by MicroVention, Inc.

K163154Traxcess 7 Mini XSoft Guidewire K161803Traxcess .007 Mini Guidewire K161367HydroCoil Embolic System (HES) K161452MicroPlex Coil System (MCS) - HyperSoft 3D K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System

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Related Devices (Code: MOF)

K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc. K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipAsahi Intecc Co., Ltd. K161803Traxcess .007 Mini GuidewireMicroVention, Inc. K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)Asahi Intecc Co., Ltd. K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd. K182337HYBRID GuidewireBalt USA, LLC

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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