đź“Š Evidence-Based Reference
wilson biomedical coronary guiding catheter
Wilson Biomedical
Summary: The Wilson Biomedical Coronary Guiding Catheter is a device used in coronary interventions. It is primarily used to guide other instruments into coronary arteries. Key evidence includes studies on imaging and procedural efficacy.
FDA Clearance Information
Pathway 510K
Number K881793 ↗
Decision Date October 19, 1988
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Wilson Biomedical Coronary Guiding Catheter was cleared through the FDA 510(k) pathway on October 19, 1988. It is manufactured by Wilson Biomedical and classified as a Class 2 device.
What It Is
The Wilson Biomedical Coronary Guiding Catheter is designed to facilitate the introduction and guidance of interventional devices into the coronary arteries. It is used in various coronary procedures to ensure accurate placement of therapeutic devices.
Clinical Applications
This catheter is commonly used in percutaneous coronary interventions (PCI) to navigate and deliver stents or other therapeutic devices to specific sites within the coronary arteries. It is essential in procedures requiring precise device placement.
Evidence Summary
The available literature includes 7 studies, with types ranging from RCTs to retrospective analyses. The studies span from 2009 to 2025, focusing on imaging techniques and procedural outcomes in coronary interventions.
Reported Outcomes
Published studies report improvements in procedural accuracy and outcomes when using the Wilson Biomedical Coronary Guiding Catheter. Imaging studies highlight its role in enhancing visualization and device delivery during coronary interventions.
Safety Profile
Reported complications include potential issues related to catheter navigation and placement, such as vessel trauma or dissection. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating this specific 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 Wilson Biomedical Coronary Guiding Catheter?
The catheter is indicated for use in coronary interventions to guide therapeutic devices into coronary arteries.
What outcomes have been reported in clinical studies?
Studies report enhanced procedural accuracy and improved imaging during coronary interventions.
What complications have been reported?
Safety data is limited, but potential complications include vessel trauma or dissection during catheter navigation.
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.