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FDA 510(k)

Tractus Crossing Support Catheter

K-Number: K180889 · 2018-12-07

ApplicantTractus Vascular, LLC
Decision Date2018-12-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tractus Crossing Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Tractus Vascular, LLC. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K180889. 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 Tractus Crossing Support Catheter?

Tractus Crossing Support Catheter is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Tractus Vascular, LLC. The 510(k) number is K180889.

When did Tractus Crossing Support Catheter receive FDA 510(k) clearance?

Tractus Crossing Support Catheter received FDA 510(k) clearance on 2018-12-07, under 510(k) number K180889.

Who is the listed applicant for Tractus Crossing Support Catheter?

The FDA 510(k) record lists Tractus Vascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tractus Crossing Support Catheter?

The FDA product code for Tractus Crossing Support Catheter is DQY.

Other records listing Tractus Vascular, LLC 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.

K221163Tunnel Crossing CatheterK183305Crossing Support 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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