đź“Š Evidence-Based Reference
modified hd guide catheter
Concentric Medical
Summary: The modified HD guide catheter by Concentric Medical is used in venous stent procedures. It was FDA 510k cleared in 2014. Key evidence includes studies on catheter mapping and surgical techniques.
FDA Clearance Information
Pathway
510K
Number
K133177 ↗
Decision Date
February 25, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modified HD guide catheter received FDA clearance through the 510k pathway on February 25, 2014. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The modified HD guide catheter is a medical device used in venous stent procedures. It facilitates the placement and navigation of stents within the venous system, aiding in the treatment of vascular conditions.
Clinical Applications
This device is commonly used in clinical scenarios involving venous stenting, particularly in cases requiring precise catheter navigation and placement. It is utilized in interventional radiology and vascular surgery settings.
Evidence Summary
The available literature includes 9 studies, comprising various study types such as RCTs and case series, published between 2015 and 2021. These studies explore catheter mapping, surgical techniques, and other related topics.
Reported Outcomes
Published studies report that the modified HD guide catheter is effective in facilitating venous stent procedures, with improved catheter mapping and surgical outcomes. The device has been associated with successful stent placements and enhanced procedural efficiency.
Safety Profile
Reported complications include potential risks associated with catheter navigation and placement, such as vascular injury or device malposition. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the modified HD guide catheter. Further research is needed to assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for modified HD guide catheter?
The device is indicated for use in venous stent procedures, aiding in the placement and navigation of stents within the venous system.
What outcomes have been reported in clinical studies?
Studies report successful stent placements and improved procedural efficiency with the use of the modified HD guide catheter.
What complications have been reported?
Safety data is limited, but potential complications include vascular injury and device malposition during catheter navigation and placement.
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.