FDA 510(k)

GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15

K-Number: K091582 · 2009-12-04

Decision Date2009-12-04

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K091582. 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 GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15?

GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Medtronic Vascular. The 510(k) number is K091582.

When did GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 receive FDA 510(k) clearance?

GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 received FDA 510(k) clearance on 2009-12-04, under 510(k) number K091582.

Who is the listed applicant for GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15?

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

What is the FDA product code for GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15?

The FDA product code for GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 is 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.