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 the device name listed in this FDA 510(k) record. The listed applicant is Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) 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. The listed applicant is Texasmedical Technologies, Inc.. The 510(k) number is K170915.

When did TXM Hydrophilic Guidewire receive FDA 510(k) clearance?

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

Who is the listed applicant for TXM Hydrophilic Guidewire?

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

What is the FDA product code for TXM Hydrophilic Guidewire?

The FDA product code for TXM Hydrophilic Guidewire is DQX.

Other records listing Texasmedical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170914TXM Support Catheter K153771TXM Guiding Sheath K153703Guiding Catheter K153125IntraNovo Microcatheter

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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.