đź“‹ FDA Reference
glidesheath slender tibial pedal kit
Terumo Medical
Summary: The Glidesheath Slender Tibial Pedal Kit by Terumo Medical is a sheath system used for vascular access in the lower extremities. It is typically used by interventional radiologists and cardiologists for procedures involving embolization coils.
FDA Clearance Information
Pathway
510K
Number
K181237 ↗
Decision Date
August 3, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Glidesheath Slender Tibial Pedal Kit was cleared by the FDA through the 510(k) pathway on August 3, 2018. Manufactured by Terumo Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Glidesheath Slender Tibial Pedal Kit is a specialized vascular access device designed to facilitate procedures in the tibial and pedal arteries. It features a slender profile to minimize vascular trauma and improve patient comfort. The device is engineered to provide reliable access for the delivery of embolization coils and other interventional tools, supporting a range of endovascular procedures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring access to the lower extremity arteries, such as embolization to treat peripheral artery disease or aneurysms. It is particularly useful in settings where minimally invasive techniques are preferred, and it is suitable for use in both hospital and outpatient environments. The kit is designed for adult patients with conditions necessitating precise vascular interventions.
Indications for Use
The FDA indications for the Glidesheath Slender Tibial Pedal Kit include its use in facilitating vascular access for procedures involving embolization coils. It is intended for patients requiring intervention in the tibial and pedal arteries, 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 interventional tools, and clinicians should be familiar with its insertion technique to optimize outcomes. Proper sizing and technique are crucial to minimize complications and ensure procedural success.
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, primarily for procedures involving embolization coils.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device for endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating vascular access in the tibial and pedal arteries for procedures involving embolization coils.
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.