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carotid access kit
Terumo Medical
Summary: The carotid access kit by Terumo Medical is designed for vascular access in carotid artery procedures. It is primarily used in embolization and stenting interventions. Key evidence highlights its role in facilitating carotid endarterectomy and thrombectomy.
FDA Clearance Information
Pathway
510K
Number
K060666 ↗
Decision Date
June 29, 2006
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The carotid access kit was cleared by the FDA through the 510(k) pathway on June 29, 2006. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The carotid access kit is a medical device used to gain vascular access to the carotid artery. It is intended for use in procedures such as embolization and stenting, providing clinicians with the necessary tools to perform these interventions safely and effectively.
Clinical Applications
This device is commonly used in clinical scenarios involving carotid artery interventions, such as carotid endarterectomy and thrombectomy. It is particularly useful in cases of carotid stenosis and vessel occlusion, where precise access is crucial.
Evidence Summary
The available literature includes a mix of study types, with a total of 7 studies ranging from 2014 to 2025. These studies explore various aspects of carotid interventions, including procedural techniques and outcomes.
Reported Outcomes
Published studies report that the carotid access kit facilitates successful carotid endarterectomy and thrombectomy procedures. It has been associated with improved access and procedural efficiency in cases of carotid stenosis and occlusion.
Safety Profile
Reported complications include potential risks associated with vascular access, such as bleeding and vessel injury. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence base is limited by the small number of studies and the lack of comprehensive safety data. Further research is needed to fully understand the long-term outcomes and potential complications associated with the use of this device.
Frequently Asked Questions
What are the clinical indications for the carotid access kit?
The carotid access kit is indicated for use in carotid artery procedures, such as embolization and stenting, particularly in cases of carotid stenosis and vessel occlusion.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful facilitation of carotid endarterectomy and thrombectomy, with improved procedural efficiency in treating carotid stenosis and occlusion.
What complications have been reported?
Reported complications include risks associated with vascular access, such as bleeding and vessel injury, though specific safety data is 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.