đź“‹ FDA Reference
preface guiding sheath models 2-603m 2-703m 2-803m 2-903m 2-1003m 2-1103m
Biosense Webster
Summary: The Preface Guiding Sheath is a catheter device used primarily in interventional cardiology and radiology for guiding other instruments during procedures. It is used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K001139 ↗
Decision Date
May 10, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Preface Guiding Sheath by Biosense Webster was cleared through the FDA 510(k) pathway on May 10, 2000. It is classified as a Class 2 device under product code DYB.
What It Is
The Preface Guiding Sheath is a flexible catheter designed to facilitate the introduction and positioning of interventional devices within the vascular system. It provides support and stability for the passage of other catheters and instruments during procedures. The sheath's design allows for smooth navigation through blood vessels, minimizing trauma to vessel walls.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Preface Guiding Sheath is employed in procedures such as angioplasty, stent placement, and embolization. It is particularly useful in complex vascular interventions where precise control and support of other devices are necessary. The sheath is suitable for use in both adult and pediatric patient populations.
Indications for Use
The Preface Guiding Sheath is indicated for use in procedures requiring vascular access and guidance of other devices within the vascular system. It is used in patients undergoing interventions that involve the placement of coils or other embolic materials.
Practical Considerations
The Preface Guiding Sheath comes in various sizes, typically ranging from 6 to 11 French, to accommodate different procedural needs. It is compatible with a wide range of interventional devices, and its hydrophilic coating aids in smooth insertion and navigation. Proper technique and familiarity with the device are essential for optimal performance.
Frequently Asked Questions
What is the Preface Guiding Sheath used for?
The Preface Guiding Sheath is used to guide and support other interventional devices during vascular procedures such as angioplasty and embolization.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the Preface Guiding Sheath in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular access and guidance of other devices during procedures involving embolization coils or similar interventions.
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.