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FDA 510(k)

GTX 12 GIDEWIRE

K-Number: K100470 · 2010-04-21

ApplicantMedtronic, Inc.
Decision Date2010-04-21
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GTX 12 GIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2010-04-21 under 510(k) number K100470. 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 GTX 12 GIDEWIRE?

GTX 12 GIDEWIRE is a medical device that received FDA 510(k) clearance on 2010-04-21. The listed applicant is Medtronic, Inc.. The 510(k) number is K100470.

When did GTX 12 GIDEWIRE receive FDA 510(k) clearance?

GTX 12 GIDEWIRE received FDA 510(k) clearance on 2010-04-21, under 510(k) number K100470.

Who is the listed applicant for GTX 12 GIDEWIRE?

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

What is the FDA product code for GTX 12 GIDEWIRE?

The FDA product code for GTX 12 GIDEWIRE 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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