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strada carotid guiding sheath
St Jude Medical
Summary: The Strada Carotid Guiding Sheath is a medical device used in vascular procedures to provide support and access to the carotid arteries. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K070166 ↗
Decision Date
April 6, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Strada Carotid Guiding Sheath by St Jude Medical was cleared through the FDA 510k pathway on April 6, 2007. It is classified as a Class 2 device under product code DYB.
What It Is
The Strada Carotid Guiding Sheath is a flexible tube designed to facilitate the insertion of catheters and other devices into the carotid arteries. It provides stability and support during vascular interventions, allowing for precise navigation and placement of embolization coils or other therapeutic devices. Its design helps minimize trauma to the vessel walls during procedures.
Clinical Applications
This device is commonly used in endovascular procedures, particularly in the treatment of carotid artery disease. It is utilized in settings such as interventional radiology suites and vascular surgery centers. The sheath is beneficial for patients requiring embolization or other interventions to address stenosis or aneurysms in the carotid arteries.
Indications for Use
The Strada Carotid Guiding Sheath is indicated for use in patients undergoing procedures that require access to the carotid arteries, such as the placement of embolization coils. It is suitable for conditions like carotid artery stenosis or aneurysms.
Practical Considerations
The sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and devices used in vascular interventions. Clinicians should be familiar with the technique of sheath insertion to minimize complications.
Frequently Asked Questions
What is the Strada Carotid Guiding Sheath used for?
It is used to provide support and access to the carotid arteries during vascular procedures, such as the placement of embolization coils.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring access to the carotid arteries, such as treating carotid artery stenosis or aneurysms.
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.