đź“‹ FDA Reference
halo one thin-walled guiding sheath
C.R. Bard
Summary: The Halo One Thin-Walled Guiding Sheath is a medical device used in vascular procedures to facilitate the introduction of interventional devices. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K212708 ↗
Decision Date
September 23, 2021
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 September 23, 2021. 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 a specialized catheter designed to provide a conduit for the insertion of other interventional devices into the vascular system. Its thin-walled construction allows for a larger inner diameter while maintaining flexibility and strength, which is crucial for navigating through blood vessels. This device is essential in procedures requiring precise placement of embolization coils or other therapeutic devices.
Clinical Applications
This guiding sheath is commonly used in interventional radiology and cardiology, particularly in procedures involving embolization, where precise device placement is critical. It is used in settings such as hospitals and specialized clinics, catering to patient populations requiring vascular interventions, including those with aneurysms or vascular malformations. The sheath's design facilitates the safe and effective delivery of coils and other devices to targeted sites within the vasculature.
Indications for Use
The FDA indications for the Halo One Thin-Walled Guiding Sheath include its use in facilitating the introduction of interventional devices during vascular procedures. It is intended for patients requiring embolization or other vascular interventions, aiding in the precise delivery of therapeutic devices.
Practical Considerations
The Halo One 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 its handling and insertion techniques to maximize its effectiveness and minimize complications.
Frequently Asked Questions
What is the Halo One Thin-Walled Guiding Sheath used for?
It is used to facilitate the introduction of interventional devices during vascular procedures, such as embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the introduction of interventional devices during vascular procedures.
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.