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modified hd guide catheter
Concentric Medical
Summary: The modified HD guide catheter by Concentric Medical is used in venous stenting procedures. It is FDA 510k cleared with evidence from 9 studies supporting its use.
FDA Clearance Information
Pathway
510K
Number
K110483 ↗
Decision Date
April 4, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modified HD guide catheter was cleared through the FDA 510k pathway on April 4, 2011. Manufactured by Concentric Medical, it is classified as a Class 2 device.
What It Is
The modified HD guide catheter is a medical device designed for use in venous stenting procedures. It facilitates the delivery of stents to targeted venous sites, aiding in the treatment of vascular conditions.
Clinical Applications
This device is commonly used in procedures requiring venous stenting, particularly in cases where precise catheter guidance is necessary to ensure accurate stent placement.
Evidence Summary
The literature includes 9 studies, encompassing various study types such as RCTs and case series, published between 2015 and 2021. These studies provide insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the modified HD guide catheter is effective in facilitating venous stenting procedures. The device has been shown to improve stent placement accuracy and procedural success rates in clinical settings.
Safety Profile
Reported complications include typical risks associated with catheter use, such as vascular injury or infection. However, specific safety data from the provided studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device. Further research is needed to establish long-term outcomes and safety profiles in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the modified HD guide catheter?
The device is indicated for use in venous stenting procedures, aiding in the delivery and placement of stents.
What outcomes have been reported in clinical studies?
Studies report improved stent placement accuracy and procedural success rates.
What complications have been reported?
Safety data indicate potential risks such as vascular injury or infection, though specific study findings are limited.
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.