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catheter percutaneous introduc sheath
Usci, Div. C.R. Bard
Summary: The catheter percutaneous introduc sheath is a medical device used to facilitate the insertion of catheters into blood vessels. It is commonly used by interventional radiologists and cardiologists in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K770561 ↗
Decision Date
April 26, 1977
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter percutaneous introduc sheath was cleared through the FDA 510k pathway on April 26, 1977. It is manufactured by Usci, Div. C.R. Bard and is classified as a Class 2 medical device.
What It Is
This device is a sheath that allows for the percutaneous introduction of catheters into blood vessels. It is designed to provide a stable and secure entry point for catheters, minimizing trauma to the vessel. The sheath is typically made of biocompatible materials and may include features such as hemostatic valves to prevent blood loss during catheter insertion.
Clinical Applications
The catheter percutaneous introduc sheath is commonly used in interventional radiology and cardiology for procedures such as angiography, angioplasty, and the deployment of embolization coils. It is used in hospital settings, particularly in catheterization labs, and is suitable for a wide range of patient populations requiring vascular access.
Indications for Use
The FDA indications suggest that this device is used for facilitating the insertion of catheters into blood vessels. It is suitable for patients undergoing procedures that require vascular access, such as diagnostic imaging or therapeutic interventions.
Practical Considerations
Clinicians should consider the appropriate sheath size based on the catheter and vessel size. Compatibility with other devices, such as guidewires and catheters, is essential. Proper technique in insertion and removal is crucial to minimize vessel trauma and complications.
Frequently Asked Questions
What is the catheter percutaneous introduc sheath used for?
It is used to facilitate the insertion of catheters into blood vessels for various medical procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the insertion of catheters into blood vessels for diagnostic or therapeutic 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.