đź“Š Evidence-Based Reference
coda balloon catheter
Cook
Summary: The Coda Balloon Catheter is a medical device used primarily for vascular interventions. Key evidence highlights its use in aortic aneurysm repairs and bronchial blockade.
FDA Clearance Information
Pathway
510K
Number
K122917 ↗
Decision Date
June 28, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Coda Balloon Catheter was cleared by the FDA through the 510(k) pathway on June 28, 2013. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Coda Balloon Catheter is a semi-compliant balloon catheter designed for vascular interventions. It is used to occlude blood vessels or to assist in the placement of other endovascular devices.
Clinical Applications
Commonly used in procedures such as aortic aneurysm repair and bronchial blockade. It provides support for device advancement and vessel occlusion in complex vascular surgeries.
Evidence Summary
The literature includes 12 studies, comprising various study types such as RCTs and case series, published between 2023 and 2025. These studies explore its application in vascular and bronchial procedures.
Reported Outcomes
Published studies report the Coda Balloon Catheter as effective in supporting endovascular device placement and achieving vascular occlusion. It has been used successfully in aortic aneurysm repairs and bronchial blockade.
Safety Profile
Reported complications include potential vascular injury and device-related malfunctions. However, specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale RCTs and detailed safety outcomes. Further research is needed to establish long-term efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Coda Balloon Catheter?
The Coda Balloon Catheter is indicated for use in vascular interventions such as aortic aneurysm repair and bronchial blockade.
What outcomes have been reported in clinical studies?
Studies report effective support in device placement and vascular occlusion, particularly in aortic aneurysm repairs.
What complications have been reported?
Reported complications include potential vascular injury and device-related malfunctions, though specific details are limited.
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.