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usci input introducer set
Usci, Div. C.R. Bard
Summary: The Usci Input Introducer Set is a medical device used for introducing catheters or other instruments into the vascular system. It is primarily used by interventional radiologists and cardiologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K940092 ↗
Decision Date August 10, 1995
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Usci Input Introducer Set was cleared through the FDA 510(k) pathway on August 10, 1995. Manufactured by Usci, Div. C.R. Bard, it is classified as a Class 2 device under product code DYB.
What It Is
The Usci Input Introducer Set is a sterile, single-use device designed to facilitate the insertion of catheters into the vascular system. It typically consists of a sheath and dilator, which help in the smooth passage of catheters into blood vessels. This device is crucial in procedures requiring vascular access, ensuring minimal trauma to the vessel wall.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Usci Input Introducer Set is essential for procedures such as angiography, embolization, and catheter-based interventions. It is used in both diagnostic and therapeutic settings, often in hospitals or specialized outpatient centers, and is suitable for adult and pediatric patients requiring vascular access.
Indications for Use
The device is indicated for use in patients requiring vascular access for procedures like embolization or catheterization. It is suitable for conditions where minimally invasive vascular access is necessary.
Practical Considerations
The Usci Input Introducer Set comes in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with a range of catheters and guidewires, and clinicians should be familiar with the specific technique for sheath insertion to minimize complications.
Frequently Asked Questions
What is Usci Input Introducer Set used for?
It is used for introducing catheters or other instruments into the vascular system during procedures like angiography and embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device in hospital and specialized outpatient settings.
What are the FDA-cleared indications?
The device is cleared for use in facilitating vascular access for procedures requiring catheter insertion, such as embolization and angiography.
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.