đź“‹ FDA Reference
glidesheath slender tibial pedal kit
Terumo Medical Coporation
Summary: The Glidesheath Slender Tibial Pedal Kit is a medical device used for vascular access in the lower extremities, particularly in interventional radiology and cardiology. It is primarily used by clinicians performing minimally invasive procedures.
FDA Clearance Information
Pathway
510K
Number
K193160 ↗
Decision Date
December 3, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath Slender Tibial Pedal Kit was cleared through the FDA 510(k) pathway on December 3, 2019, by Terumo Medical Corporation. It is classified as a Class 2 device under product code DYB.
What It Is
The Glidesheath Slender Tibial Pedal Kit is a specialized sheath system designed for vascular access in the tibial and pedal arteries. It features a slender profile to minimize trauma to the vessel and is used to facilitate the introduction of catheters and other devices into the vascular system. This device is particularly useful in procedures requiring access to smaller, more distal vessels.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as peripheral artery disease interventions and embolization. It is suitable for use in hospital settings, particularly in catheterization labs, and is often employed in patients with complex vascular anatomy or those requiring access to distal vessels in the lower extremities.
Indications for Use
The FDA-cleared indications for this device include use in procedures requiring vascular access in the tibial and pedal arteries. It is designed for patients needing interventions in these smaller, distal vessels, often due to conditions like peripheral artery disease.
Practical Considerations
The Glidesheath Slender Tibial Pedal Kit typically comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and guidewires, and clinicians should be familiar with the technique for accessing distal vessels to optimize outcomes.
Frequently Asked Questions
What is the Glidesheath Slender Tibial Pedal Kit used for?
It is used for vascular access in the tibial and pedal arteries during minimally invasive procedures.
What specialties typically use this device?
Interventional cardiology and radiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in the tibial and pedal arteries, particularly for interventions in distal vessels.
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.