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FDA 510(k)

GORE Tri-Lumen Catheter

K-Number: K180919 · 2018-10-05

ApplicantW. L. Gore and Associates, Inc.
Decision Date2018-10-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE Tri-Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore and Associates, Inc.. It received FDA 510(k) clearance on 2018-10-05 under 510(k) number K180919. 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 GORE Tri-Lumen Catheter?

GORE Tri-Lumen Catheter is a medical device that received FDA 510(k) clearance on 2018-10-05. The listed applicant is W. L. Gore and Associates, Inc.. The 510(k) number is K180919.

When did GORE Tri-Lumen Catheter receive FDA 510(k) clearance?

GORE Tri-Lumen Catheter received FDA 510(k) clearance on 2018-10-05, under 510(k) number K180919.

Who is the listed applicant for GORE Tri-Lumen Catheter?

The FDA 510(k) record lists W. L. Gore and Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE Tri-Lumen Catheter?

The FDA product code for GORE Tri-Lumen Catheter is DQY.

Other records listing W. L. Gore and Associates, 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.

PMA P200030SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTK222919GORE® ENFORM BiomaterialK172567GORE Molding and Occlusion Balloon Catheter

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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