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j-cath gish model no jvac-xxxx
Gish Biomedical
Summary: The j-cath gish model no jvac-xxxx is a venous stent by Gish Biomedical, primarily used in vascular interventions. Key evidence includes FDA clearance and linked studies on venous stents.
FDA Clearance Information
Pathway
510K
Number
K863790 ↗
Decision Date
June 24, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The j-cath gish model no jvac-xxxx received FDA clearance through the 510k pathway on June 24, 1987. It is manufactured by Gish Biomedical and classified as a Class 2 device.
What It Is
The j-cath gish model no jvac-xxxx is a venous stent designed to support and maintain patency in venous vessels. It is used in clinical settings to treat venous obstructions and improve blood flow.
Clinical Applications
Commonly used in procedures addressing venous insufficiency or thrombosis, this device is applied in vascular surgeries to ensure vessel patency and prevent complications associated with venous blockages.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and meta-analyses, published between 2023 and 2024. These studies explore the clinical efficacy and safety of venous stents.
Reported Outcomes
Published studies report that venous stents, like the j-cath gish model, effectively maintain vessel patency and improve venous blood flow. Clinical outcomes include reduced symptoms of venous insufficiency and improved patient quality of life.
Safety Profile
Reported complications include potential risks of thrombosis and stent migration, as noted in the literature. However, these events are relatively rare and often manageable with appropriate clinical interventions.
Evidence Limitations
Current evidence is limited by the small number of studies directly evaluating this specific model. Further research is needed to establish long-term outcomes and compare efficacy with alternative interventions.
Frequently Asked Questions
What are the clinical indications for j-cath gish model no jvac-xxxx?
The device is indicated for use in maintaining patency in venous vessels, particularly in cases of venous obstruction or insufficiency.
What outcomes have been reported in clinical studies?
Studies report improved vessel patency and reduced symptoms of venous insufficiency, enhancing patient quality of life.
What complications have been reported?
Safety data indicate risks of thrombosis and stent migration, though these are relatively rare and manageable.
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.