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FDA 510(k)

Traxcess 14 SELECT Guidewire

K-Number: K200547 · 2020-04-16

ApplicantMicroVention, Inc.
Decision Date2020-04-16
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Traxcess 14 SELECT 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 2020-04-16 under 510(k) number K200547. 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 14 SELECT Guidewire?

Traxcess 14 SELECT Guidewire is a medical device that received FDA 510(k) clearance on 2020-04-16. The listed applicant is MicroVention, Inc.. The 510(k) number is K200547.

When did Traxcess 14 SELECT Guidewire receive FDA 510(k) clearance?

Traxcess 14 SELECT Guidewire received FDA 510(k) clearance on 2020-04-16, under 510(k) number K200547.

Who is the listed applicant for Traxcess 14 SELECT 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 14 SELECT Guidewire?

The FDA product code for Traxcess 14 SELECT 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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