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halo one thin-walled guiding sheath
C.R. Bard
Summary: The Halo One Thin-Walled Guiding Sheath is a medical device used to facilitate the introduction of interventional devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K161183 ↗
Decision Date
June 3, 2016
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Halo One Thin-Walled Guiding Sheath was cleared through the FDA 510k pathway on June 3, 2016. Manufactured by C.R. Bard, it is classified as a Class II device under product code DYB.
What It Is
The Halo One Thin-Walled Guiding Sheath is a specialized catheter designed to provide a conduit for the insertion of interventional devices into the vascular system. Its thin-walled design allows for a larger inner diameter while maintaining a smaller outer diameter, which can be beneficial in minimizing vascular trauma. The sheath is typically used in procedures requiring vascular access, such as angiography or the deployment of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly in procedures involving vascular access and intervention. It is suitable for use in hospitals and specialized clinics, where it aids in the delivery of devices like stents or embolization coils. The sheath is useful for patients requiring arterial or venous access for therapeutic or diagnostic purposes.
Indications for Use
The FDA-cleared indications for the Halo One Thin-Walled Guiding Sheath include its use in facilitating the introduction of interventional devices into the vascular system. It is intended for patients who require vascular access for procedures such as embolization or angiography.
Practical Considerations
The Halo One Thin-Walled Guiding Sheath is available in various sizes to accommodate different vascular anatomies and procedural needs. It is compatible with a range of interventional devices, and clinicians should be familiar with the appropriate technique for sheath insertion and device compatibility to ensure optimal outcomes.
Frequently Asked Questions
What is the Halo One Thin-Walled Guiding Sheath used for?
It is used to facilitate the introduction of interventional devices into the vascular system, such as during angiography or embolization procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of interventional devices into the vascular system for procedures like embolization and angiography.
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.