FDA 510(k)

TXM Guiding Sheath

K-Number: K153771 · 2016-09-13

ApplicantTexasmedical Technologies, Inc.

Decision Date2016-09-13

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TXM Guiding Sheath is a medical device manufactured by Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2016-09-13 under approval number K153771. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TXM Guiding Sheath?

TXM Guiding Sheath is a medical device that received FDA 510(k) clearance on 2016-09-13. It is manufactured by Texasmedical Technologies, Inc.. The 510(k) number is K153771.

When was TXM Guiding Sheath approved by the FDA?

TXM Guiding Sheath received FDA 510(k) clearance on 2016-09-13, under approval number K153771.

What company makes TXM Guiding Sheath?

TXM Guiding Sheath is manufactured by Texasmedical Technologies, Inc..

What is the FDA product code for TXM Guiding Sheath?

The FDA product code for TXM Guiding Sheath is DYB.

Other Devices by Texasmedical Technologies, Inc.

K153703Guiding Catheter K153125IntraNovo Microcatheter K170915TXM Hydrophilic Guidewire 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.