đź“Š Evidence-Based Reference
modification to modified hd guide catheter
Concentric Medical
Summary: The modification to the modified HD guide catheter by Concentric Medical is a Class 2 device cleared by the FDA for venous-stent applications. Key evidence includes 15 studies exploring its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K092298 ↗
Decision Date
November 5, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 5, 2009. It is manufactured by Concentric Medical and classified as a Class 2 device under product code DQY.
What It Is
The modification to the modified HD guide catheter is a medical device designed for use in venous-stent procedures. It facilitates the delivery and placement of stents within the venous system, aiding in the treatment of vascular conditions.
Clinical Applications
This device is commonly used in procedures requiring the placement of venous stents, particularly in cases where precise catheter guidance is necessary. It is utilized in interventional radiology and vascular surgery settings.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and case series, conducted between 2022 and 2025. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the modification to the modified HD guide catheter effectively aids in the placement of venous stents, improving procedural success rates. The device has shown to enhance precision in catheter guidance, contributing to positive clinical outcomes.
Safety Profile
Reported complications include minor procedural risks typical of catheter-based interventions, such as local site reactions and transient discomfort. No significant adverse events specific to the device have been highlighted in the available studies.
Evidence Limitations
The evidence base is limited by the heterogeneity of study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and comparative effectiveness against other devices.
Frequently Asked Questions
What are the clinical indications for modification to modified HD guide catheter?
The device is indicated for use in venous-stent procedures, facilitating the delivery and placement of stents within the venous system.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and enhanced precision in catheter guidance, contributing to positive clinical outcomes.
What complications have been reported?
Reported complications include minor procedural risks such as local site reactions and transient discomfort, with no significant adverse events specific to the device.
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.