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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 primarily in vascular procedures to facilitate the insertion and guidance of other instruments. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K192313 ↗
Decision Date
December 19, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Halo One Thin-Walled Guiding Sheath was cleared through the FDA 510(k) pathway on December 19, 2019. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DYB.
What It Is
The Halo One Thin-Walled Guiding Sheath is 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, facilitating easier access and maneuverability within blood vessels. This device is particularly useful in procedures requiring precise navigation and placement of catheters or other instruments.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Halo One Guiding Sheath is employed in procedures such as embolization, angioplasty, and the placement of stents or coils. It is particularly beneficial in settings requiring minimal vascular trauma and high precision, such as in patients with complex vascular anatomy or those undergoing repeated interventions.
Indications for Use
The FDA-cleared indications for the Halo One Guiding Sheath include its use in facilitating the insertion and guidance of interventional devices within the vascular system. It is suitable for patients requiring vascular access for diagnostic or therapeutic procedures.
Practical Considerations
The Halo One Guiding Sheath comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of interventional devices, and its thin-walled design aids in reducing vascular trauma. Clinicians should consider the specific vascular access site and patient condition when selecting the appropriate sheath size.
Frequently Asked Questions
What is the Halo One Thin-Walled Guiding Sheath used for?
It is used to facilitate the insertion and guidance of interventional devices within the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in facilitating the insertion and guidance of interventional devices in the vascular system.
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.