Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TrailBlazer Angled Support Catheter

K-Number: K162384 · 2016-09-22

ApplicantMedtronic Vascular, Inc.(Formerly Ev3 Inc.)
Decision Date2016-09-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TrailBlazer Angled Support Catheter is a medical device manufactured by Medtronic Vascular, Inc.(Formerly Ev3 Inc.). It received FDA 510(k) clearance on 2016-09-22 under approval number K162384. 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 TrailBlazer Angled Support Catheter?

TrailBlazer Angled Support Catheter is a medical device that received FDA 510(k) clearance on 2016-09-22. It is manufactured by Medtronic Vascular, Inc.(Formerly Ev3 Inc.). The 510(k) number is K162384.

When was TrailBlazer Angled Support Catheter approved by the FDA?

TrailBlazer Angled Support Catheter received FDA 510(k) clearance on 2016-09-22, under approval number K162384.

What company makes TrailBlazer Angled Support Catheter?

TrailBlazer Angled Support Catheter is manufactured by Medtronic Vascular, Inc.(Formerly Ev3 Inc.).

What is the FDA product code for TrailBlazer Angled Support Catheter?

The FDA product code for TrailBlazer Angled 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

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 K162359Surefire Guiding CatheterSurefire Medical, Inc. K161262Super Distal Access (SDA)Inneuroco, 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.

↑