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brite tip radianz guiding sheath
Cordis
Summary: The brite tip radianz guiding sheath is a medical device used in vascular procedures to facilitate the introduction of catheters and other devices. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K202167 ↗
Decision Date
February 26, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The brite tip radianz guiding sheath was cleared through the FDA 510k pathway on February 26, 2021. It is manufactured by Cordis and classified as a Class 2 device under product code DYB.
What It Is
The brite tip radianz guiding sheath is a specialized medical device designed to aid in the placement of catheters during vascular procedures. It features a flexible, kink-resistant design that allows for smooth navigation through the vascular system. The sheath is typically used to provide support and stability during the insertion of other interventional devices.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures that involve the placement of embolization coils or stents. It is suitable for use in both hospital and outpatient settings, and is often employed in the treatment of peripheral vascular disease, especially in patients requiring transradial access.
Indications for Use
The brite tip radianz guiding sheath is indicated for use in patients undergoing vascular procedures where the introduction of catheters is necessary. It is particularly useful in cases requiring precise navigation and stability of interventional devices.
Practical Considerations
The brite tip radianz guiding sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and interventional devices. Clinicians should be familiar with transradial access techniques when using this sheath.
Related Literature
The linked study evaluated the safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System for treating iliac and femoropopliteal lesions via transradial access. Although the abstract is not available, the study likely focused on outcomes such as procedural success and complication rates. Limitations may include a lack of long-term follow-up data.
Frequently Asked Questions
What is brite tip radianz guiding sheath used for?
It is used to facilitate the introduction of catheters and other interventional devices during vascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in vascular procedures requiring the introduction of catheters, particularly in cases needing precise navigation and stability.
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.