đź“‹ FDA Reference
exacta percutaneous introducer sheath
Ohmeda Medical
Summary: The Exacta Percutaneous Introducer Sheath is a medical device used to facilitate the insertion of catheters or other instruments into the vascular system. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K941428 ↗
Decision Date
July 6, 1994
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Exacta Percutaneous Introducer Sheath was cleared through the FDA 510(k) pathway on July 6, 1994. Manufactured by Ohmeda Medical, it is classified as a Class 2 device under product code DYB.
What It Is
The Exacta Percutaneous Introducer Sheath is a tubular device designed to provide a conduit for the insertion of catheters and other medical instruments into the vascular system. It typically consists of a sheath and dilator that allow for smooth entry into blood vessels, minimizing trauma to the vessel wall. This device is essential in procedures requiring vascular access, allowing for the safe and efficient introduction of various diagnostic and therapeutic tools.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and the placement of stents or coils. It is particularly useful in settings where precise vascular access is required, such as in hospitals and specialized outpatient centers. The sheath is suitable for a wide range of patient populations, including those undergoing minimally invasive procedures for cardiovascular or peripheral vascular conditions.
Indications for Use
The Exacta Percutaneous Introducer Sheath is indicated for use in patients requiring vascular access for diagnostic or therapeutic procedures. It is particularly suited for conditions that necessitate the insertion of catheters or other instruments into the vascular system, such as during embolization procedures.
Practical Considerations
The sheath is available in various sizes to accommodate different vessel diameters and procedural requirements. It is compatible with a range of catheters and instruments, making it versatile for multiple clinical applications. Clinicians should be familiar with the technique for inserting the sheath to minimize the risk of vascular injury.
Frequently Asked Questions
What is the Exacta Percutaneous Introducer Sheath used for?
It is used to facilitate the insertion of catheters and other instruments into the vascular system during diagnostic and therapeutic procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in providing vascular access for diagnostic or therapeutic procedures, such as during embolization.
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.