đź“‹ FDA Reference
cvi 8 5 french percutaneous sheath introducer sys
Cardio-Vascular Innovations
Summary: The CVI 8 5 French Percutaneous Sheath Introducer System is a medical device used to facilitate the insertion of catheters and other devices into the vascular system. It is primarily used by interventional cardiologists and radiologists during procedures such as angiography and embolization.
FDA Clearance Information
Pathway
510K
Number
K863917 ↗
Decision Date
January 6, 1987
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The CVI 8 5 French Percutaneous Sheath Introducer System was cleared through the FDA's 510(k) pathway on January 6, 1987. Manufactured by Cardio-Vascular Innovations, this device is classified as a Class 2 medical device under product code DYB.
What It Is
The CVI 8 5 French Percutaneous Sheath Introducer System is a vascular access device designed to provide a stable entry point into the vascular system for the introduction of catheters and other interventional tools. It typically consists of a sheath and dilator, allowing for smooth insertion and minimizing trauma to the vessel. This device is crucial in procedures requiring vascular access, offering a conduit for various diagnostic and therapeutic interventions.
Clinical Applications
Commonly used in interventional cardiology and radiology, this device facilitates procedures such as angiography, embolization, and other catheter-based interventions. It is used in hospital settings, particularly in catheterization labs and interventional radiology suites. The device is suitable for adult patients requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The FDA indications for this device include its use in providing vascular access for the introduction of catheters and other medical devices. It is intended for patients undergoing procedures that require access to the vascular system, such as angiographic studies or embolization therapies.
Practical Considerations
The 8 5 French sizing indicates the outer diameter of the sheath, which is compatible with a range of catheters and devices. Clinicians should ensure compatibility with the intended catheters and consider vessel size and patient anatomy when selecting the appropriate sheath size. Proper technique in insertion and maintenance of the sheath is crucial to minimize complications such as bleeding or vessel trauma.
Frequently Asked Questions
What is the CVI 8 5 French Percutaneous Sheath Introducer System used for?
It is used to provide vascular access for the insertion of catheters and other interventional devices during procedures such as angiography and embolization.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs and interventional radiology suites.
What are the FDA-cleared indications?
The device is indicated for providing vascular access for the introduction of catheters and other medical devices in procedures requiring access to the vascular system.
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.