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FDA 510(k)

Crossing Support Catheter

K-Number: K183305 · 2019-08-05

ApplicantTractus Vascular, LLC
Decision Date2019-08-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 2019-08-05 under 510(k) number K183305. 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 Crossing Support Catheter?

Crossing Support Catheter is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Tractus Vascular, LLC. The 510(k) number is K183305.

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

Crossing Support Catheter received FDA 510(k) clearance on 2019-08-05, under 510(k) number K183305.

Who is the listed applicant for 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 Crossing Support Catheter?

The FDA product code for 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 CatheterK180889Tractus Crossing 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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