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FDA 510(k)

Traxcess .007 Mini Guidewire

K-Number: K161803 · 2016-09-30

ApplicantMicroVention, Inc.
Decision Date2016-09-30
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Traxcess .007 Mini Guidewire is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2016-09-30 under approval number K161803. 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 .007 Mini Guidewire?

Traxcess .007 Mini Guidewire is a medical device that received FDA 510(k) clearance on 2016-09-30. It is manufactured by MicroVention, Inc.. The 510(k) number is K161803.

When was Traxcess .007 Mini Guidewire approved by the FDA?

Traxcess .007 Mini Guidewire received FDA 510(k) clearance on 2016-09-30, under approval number K161803.

What company makes Traxcess .007 Mini Guidewire?

Traxcess .007 Mini Guidewire is manufactured by MicroVention, Inc..

What is the FDA product code for Traxcess .007 Mini Guidewire?

The FDA product code for Traxcess .007 Mini Guidewire is MOF.

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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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