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FDA 510(k)

Traxcess 7 Mini XSoft Guidewire

K-Number: K163154 · 2016-12-09

ApplicantMicroVention, Inc.
Decision Date2016-12-09
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Traxcess 7 Mini XSoft Guidewire is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2016-12-09 under approval number K163154. 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 XSoft Guidewire?

Traxcess 7 Mini XSoft Guidewire is a medical device that received FDA 510(k) clearance on 2016-12-09. It is manufactured by MicroVention, Inc.. The 510(k) number is K163154.

When was Traxcess 7 Mini XSoft Guidewire approved by the FDA?

Traxcess 7 Mini XSoft Guidewire received FDA 510(k) clearance on 2016-12-09, under approval number K163154.

What company makes Traxcess 7 Mini XSoft Guidewire?

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

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

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

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Related Devices (Code: MOF)

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 K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard ProfileScientia Vascular, 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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