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funnel guide catheter model g1020608
Lazarus Effect
Summary: The funnel guide catheter model g1020608 by Lazarus Effect is a Class 2 medical device cleared by the FDA for use in venous stenting procedures. Key evidence highlights its application in venous interventions, with studies focusing on efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K102439 ↗
Decision Date
January 12, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The funnel guide catheter model g1020608 was cleared through the FDA 510(k) pathway on January 12, 2012. Manufactured by Lazarus Effect, it is classified as a Class 2 device under product code DQY.
What It Is
The funnel guide catheter model g1020608 is designed to facilitate the delivery of stents in venous procedures. It aids in the precise placement of stents, ensuring optimal outcomes in venous interventions.
Clinical Applications
This device is commonly used in procedures involving venous stenting, particularly in cases requiring precise catheter guidance. It is employed in both routine and complex venous interventions.
Evidence Summary
The available literature includes 9 studies, encompassing various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2020 to 2026, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the funnel guide catheter model g1020608 is effective in facilitating venous stenting procedures, with a focus on improving procedural success rates. The device has been associated with enhanced precision in stent placement, contributing to favorable clinical outcomes.
Safety Profile
Reported complications include concerns related to vascular access, as highlighted in studies focusing on venous closure systems. However, specific adverse events directly linked to the funnel guide catheter model g1020608 are not extensively documented in the provided evidence.
Evidence Limitations
The evidence base is limited by the lack of long-term follow-up data and the need for more randomized controlled trials to establish definitive safety and efficacy profiles. Further research is needed to explore the device's performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for funnel guide catheter model g1020608?
The device is indicated for use in venous stenting procedures, aiding in the precise delivery and placement of stents.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and enhanced precision in stent placement when using the funnel guide catheter model g1020608.
What complications have been reported?
Safety data indicate concerns related to vascular access, but specific adverse events directly linked to the device are not extensively documented.
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.