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boosting catheter
Qxmedical
Summary: The boosting catheter by Qxmedical is a device used primarily in venous stenting procedures. It was FDA cleared via the 510k pathway in 2016. Key evidence highlights its role in enhancing interventional treatment options for cardiovascular conditions.
FDA Clearance Information
Pathway
510K
Number
K160561 ↗
Decision Date
November 2, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The boosting catheter was cleared by the FDA through the 510k pathway on November 2, 2016. It is manufactured by Qxmedical and classified as a Class 2 device under product code DQY.
What It Is
The boosting catheter is a medical device designed to assist in venous stenting procedures. It functions by providing enhanced support and precision during the placement of stents in venous structures, thereby improving the efficacy of the intervention.
Clinical Applications
Commonly used in procedures involving venous stents, the boosting catheter is particularly beneficial in cases requiring precise stent placement. It is utilized in interventional cardiology and radiology settings to address venous obstructions.
Evidence Summary
The available literature consists of 11 studies, including cross-sectional and prospective designs, published between 2022 and 2025. These studies explore various aspects of catheter use in interventional procedures.
Reported Outcomes
Published studies report that the boosting catheter enhances the precision and success rates of venous stenting procedures. It has been associated with improved patient outcomes in terms of reduced procedural time and increased stent stability.
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 have been consistently reported across studies.
Evidence Limitations
The evidence base is limited by the heterogeneity of study designs and small sample sizes in some studies. Further research is needed to establish long-term outcomes and comparative effectiveness against alternative devices.
Frequently Asked Questions
What are the clinical indications for boosting catheter?
The boosting catheter is indicated for use in venous stenting procedures, particularly in cases requiring enhanced precision and support during stent placement.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved precision and success rates in venous stenting procedures, with enhanced stent stability and reduced procedural time.
What complications have been reported?
Safety data from evidence indicate minor procedural risks such as local site reactions and transient discomfort, with no significant adverse events consistently reported.
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.