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FDA 510(k)

Guiding Catheter

K-Number: K153703 · 2016-05-12

Decision Date2016-05-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Guiding Catheter is a medical device manufactured by Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-12 under approval number K153703. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guiding Catheter?

Guiding Catheter is a medical device that received FDA 510(k) clearance on 2016-05-12. It is manufactured by Texasmedical Technologies, Inc.. The 510(k) number is K153703.

When was Guiding Catheter approved by the FDA?

Guiding Catheter received FDA 510(k) clearance on 2016-05-12, under approval number K153703.

What company makes Guiding Catheter?

Guiding Catheter is manufactured by Texasmedical Technologies, Inc..

What is the FDA product code for Guiding Catheter?

The FDA product code for Guiding Catheter is DQY.

Related Clinical Trials

Other Devices by Texasmedical Technologies, Inc.

Related Devices (Code: DQY)

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.