📋 FDA Reference
Halo One Thin-Walled Guiding Sheath
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of the introduction of interventional devices into the vascular system.
Clinical Applications
- Providing vascular access during diagnostic angiography.
- Providing a conduit for interventional devices used in embolization procedures.
- Supporting the introduction of vascular devices during arterial or venous interventions.
Practical Considerations
- Available sizes and configurations must be selected according to the access vessel, target anatomy, and device requirements.
- Clinicians should confirm compatibility between the sheath's inner diameter, length, guidewires, catheters, and other interventional devices before use.
- Insertion is generally performed over a guidewire using fluoroscopic or other image guidance, with sterile technique and appropriate local anesthesia or sedation.
- The device should be used according to its current labeling and instructions for use, including warnings, contraindications, and access-site requirements.
- MRI safety depends on the exact product configuration and labeling; the device should not be assumed to be MR safe or MR conditional without verification.
Procedures that use this device
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.