FDA 510(k)

Tractus Crossing Support Catheter

K-Number: K180889 · 2018-12-07

Decision Date2018-12-07

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Tractus Crossing Support Catheter is a medical device manufactured by Tractus Vascular, LLC. It received FDA 510(k) clearance on 2018-12-07 under approval 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. It is manufactured by Tractus Vascular, LLC. The 510(k) number is K180889.

When was Tractus Crossing Support Catheter approved by the FDA?

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

What company makes Tractus Crossing Support Catheter?

Tractus Crossing Support Catheter is manufactured by Tractus Vascular, LLC.

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

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

Related Clinical Trials

NCT07552272 Hummingbird ICE Study NOT_YET_RECRUITING NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT02761889 Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer COMPLETED NCT04035642 Single-Dose Image-Guided Radiotherapy With Urethral Sparing and DIL Boost for Intermediate-Risk Prostate Cancer (PROSINT II) RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

Other Devices by Tractus Vascular, LLC

K183305Crossing Support Catheter K221163Tunnel Crossing Catheter

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, Inc.

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.