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FDA 510(k)

Guiding Catheter

K-Number: K153703 · 2016-05-12

ApplicantTexasmedical Technologies, Inc.
Decision Date2016-05-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Guiding Catheter 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 2016-05-12 under 510(k) 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. The listed applicant is Texasmedical Technologies, Inc.. The 510(k) number is K153703.

When did Guiding Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Guiding Catheter?

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 Guiding Catheter?

The FDA product code for Guiding Catheter is DQY.

Related Clinical Trials

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.

NCT06009757GUIDEX® Versus Launcher™ Guiding Catheter in Percutaneous Coronary Intervention (PCI) (GUIDEX_FR)COMPLETED

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.

K170915TXM Hydrophilic GuidewireK170914TXM Support CatheterK153771TXM Guiding SheathK153125IntraNovo Microcatheter

Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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.

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