đź“‹ FDA Reference
rain sheath tibial pedal introducer
Cordis Us
Summary: The Rain Sheath Tibial Pedal Introducer is a medical device used for vascular access in the lower extremities, particularly in tibial and pedal arteries. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K230704 ↗
Decision Date
April 24, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Rain Sheath Tibial Pedal Introducer was cleared through the FDA 510k pathway on April 24, 2023. It is manufactured by Cordis Us and is classified as a Class 2 device under product code DYB.
What It Is
The Rain Sheath Tibial Pedal Introducer is a specialized catheter sheath designed for accessing small arteries in the lower extremities, such as the tibial and pedal arteries. It facilitates the introduction of interventional devices like embolization coils into these vessels. The device is designed to minimize trauma to the vessel and improve procedural outcomes.
Clinical Applications
This device is commonly used in procedures requiring vascular access in the lower extremities, such as peripheral artery disease interventions. It is particularly useful in settings where precise access to small, distal arteries is necessary. Interventional radiologists and vascular surgeons often use this device in hospital catheterization labs or outpatient vascular centers.
Indications for Use
The FDA indications suggest that this device is intended for use in patients requiring vascular access in the tibial and pedal arteries. It is suitable for conditions where embolization or other interventional procedures are necessary.
Practical Considerations
The Rain Sheath Tibial Pedal Introducer comes in various sizes to accommodate different vessel diameters. It is compatible with standard interventional tools and requires careful handling to avoid vessel damage. Clinicians should be familiar with the anatomy of the lower extremities for optimal use.
Frequently Asked Questions
What is the Rain Sheath Tibial Pedal Introducer used for?
It is used for vascular access in the tibial and pedal arteries, facilitating interventional procedures like embolization.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in the tibial and pedal arteries, particularly for interventional 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.