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z3 guide catheter
Medtronic Vascular
Summary: The z3 guide catheter by Medtronic Vascular is a Class 2 device cleared by the FDA for use in venous stents. Key evidence includes studies on catheter positioning and radiofrequency ablation guidance.
FDA Clearance Information
Pathway
510K
Number
K021256 ↗
Decision Date
May 17, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The z3 guide catheter was cleared through the FDA 510(k) pathway on May 17, 2002. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The z3 guide catheter is designed for use in venous stenting procedures. It facilitates the placement and guidance of stents within venous structures, aiding in the treatment of vascular conditions.
Clinical Applications
Commonly used in procedures involving venous stenting, the z3 guide catheter is instrumental in ensuring accurate stent placement. It is particularly useful in scenarios requiring precise catheter positioning.
Evidence Summary
The available literature includes two studies: one exploratory pilot study and one involving transoesophageal echocardiographic evaluation. These studies span from 2018 to 2024 and include various methodologies.
Reported Outcomes
Published studies report on the efficacy of catheter positioning techniques and the potential for improved outcomes in radiofrequency ablation procedures when guided by advanced imaging techniques.
Safety Profile
Reported complications include potential misplacement of the catheter tip, which can lead to improper function or injury. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for z3 guide catheter?
The z3 guide catheter is indicated for use in venous stenting procedures, facilitating accurate stent placement.
What outcomes have been reported in clinical studies?
Studies have reported on the efficacy of catheter positioning techniques and the potential for improved outcomes in guided procedures.
What complications have been reported?
Reported complications include potential misplacement of the catheter tip, which can lead to improper function or injury.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.