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cook coda balloon catheter
Cook
Summary: The Cook Coda Balloon Catheter is a medical device used primarily for vascular occlusion and endovascular procedures. Key evidence highlights its application in minimally invasive surgeries and aortic aneurysm repairs.
FDA Clearance Information
Pathway
510K
Number
K032869 ↗
Decision Date
November 19, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cook Coda Balloon Catheter was cleared by the FDA through the 510(k) pathway on November 19, 2003. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The Cook Coda Balloon Catheter is a semi-compliant balloon catheter designed for temporary vascular occlusion. It is used in various endovascular procedures to facilitate access and intervention in vascular surgeries.
Clinical Applications
Commonly used in endovascular procedures such as aortic aneurysm repairs and minimally invasive cardiac surgeries. It provides support and occlusion in vascular interventions, enhancing procedural outcomes.
Evidence Summary
The literature includes 6 studies, encompassing RCTs, prospective, and retrospective analyses, published between 2021 and 2026. These studies explore its use in vascular occlusion and endovascular techniques.
Reported Outcomes
Published studies report the Cook Coda Balloon Catheter as effective in supporting endovascular procedures, particularly in aortic aneurysm repairs and tricuspid valve surgeries. Its use has been associated with improved procedural access and reduced manipulation risks.
Safety Profile
Reported complications include potential vascular injury and balloon rupture during procedures. However, these events are infrequent and generally manageable with proper technique.
Evidence Limitations
Current evidence is limited by small sample sizes and a focus on specific surgical applications. Further research is needed to explore broader clinical applications and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Cook Coda Balloon Catheter?
The Cook Coda Balloon Catheter is indicated for temporary vascular occlusion in endovascular procedures, such as aortic aneurysm repairs and minimally invasive cardiac surgeries.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective procedural support and improved access in vascular surgeries, with reduced manipulation risks.
What complications have been reported?
Safety data indicates potential complications such as vascular injury and balloon rupture, though these are 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.