đź“‹ FDA Reference
sheath-in-sheath catheter 18fr model s00018 sheath-in-sheath catheter 6 fr model s00019
Facile Medical
Summary: The sheath-in-sheath catheter by Facile Medical is a device used primarily in interventional radiology for procedures like embolization. It is typically used by specialists in vascular and interventional radiology.
FDA Clearance Information
Pathway
510K
Number
K042308 ↗
Decision Date
February 17, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on February 17, 2005. Manufactured by Facile Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The sheath-in-sheath catheter is a specialized medical device designed for use in vascular procedures. It consists of two concentric sheaths, allowing for enhanced maneuverability and stability during catheter-based interventions. This design is particularly useful in procedures requiring precise placement and control, such as embolization.
Clinical Applications
This device is commonly used in interventional radiology, particularly for embolization procedures where precise delivery of embolic agents is required. It is suitable for use in hospital settings, especially in catheterization labs, and is utilized by interventional radiologists and vascular surgeons. The device is applicable for adult and pediatric patients requiring vascular interventions.
Indications for Use
The sheath-in-sheath catheter is indicated for use in procedures involving the delivery of embolization coils. It is suitable for patients requiring vascular occlusion or embolization, often due to aneurysms or vascular malformations.
Practical Considerations
The sheath-in-sheath catheter is available in sizes 18fr and 6fr, offering flexibility for different procedural needs. It is compatible with standard guidewires and embolic materials. Clinicians should ensure proper sizing and compatibility with other procedural tools to optimize outcomes.
Frequently Asked Questions
What is the sheath-in-sheath catheter used for?
It is used for delivering embolization coils during vascular procedures, particularly in interventional radiology.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the delivery of embolization coils for vascular occlusion.
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.