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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 the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) 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. The listed applicant is MicroVention, Inc.. The 510(k) number is K161803.

When did Traxcess .007 Mini Guidewire receive FDA 510(k) clearance?

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

Who is the listed applicant for Traxcess .007 Mini Guidewire?

The FDA 510(k) record lists MicroVention, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: MOF)

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.

K262424Willow 12 GuidewireArbor Endovascular, LLCK260223Aristotle Mini GuidewireScientia Vascular, Inc.K254006Drivewire 35 GuidewireRapid Medical Ltd.K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc.K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech LimitedK260537Willow 24 GuidewireArbor Endovascular, 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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