FDA 510(k)

TXM Hydrophilic Guidewire

K-Number: K170915 · 2017-11-21

ApplicantTexasmedical Technologies, Inc.

Decision Date2017-11-21

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TXM Hydrophilic Guidewire is a medical device manufactured by Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2017-11-21 under approval number K170915. 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 TXM Hydrophilic Guidewire?

TXM Hydrophilic Guidewire is a medical device that received FDA 510(k) clearance on 2017-11-21. It is manufactured by Texasmedical Technologies, Inc.. The 510(k) number is K170915.

When was TXM Hydrophilic Guidewire approved by the FDA?

TXM Hydrophilic Guidewire received FDA 510(k) clearance on 2017-11-21, under approval number K170915.

What company makes TXM Hydrophilic Guidewire?

TXM Hydrophilic Guidewire is manufactured by Texasmedical Technologies, Inc..

What is the FDA product code for TXM Hydrophilic Guidewire?

The FDA product code for TXM Hydrophilic Guidewire is DQX.

Other Devices by Texasmedical Technologies, Inc.

K153771TXM Guiding Sheath K153703Guiding Catheter K153125IntraNovo Microcatheter K170914TXM Support Catheter

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.