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FDA 510(k)

TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE

K-Number: K093397 · 2009-12-17

ApplicantMicroVention, Inc.
Decision Date2009-12-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2009-12-17 under 510(k) number K093397. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE?

TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE is a medical device that received FDA 510(k) clearance on 2009-12-17. The listed applicant is MicroVention, Inc.. The 510(k) number is K093397.

When did TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE receive FDA 510(k) clearance?

TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE received FDA 510(k) clearance on 2009-12-17, under 510(k) number K093397.

Who is the listed applicant for TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE?

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 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE?

The FDA product code for TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE is DQX.

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Related Devices (Code: DQX)

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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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