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usci r access tm introducer set
C.R. Bard
Summary: The USCI R Access TM Introducer Set is a medical device used to facilitate the introduction of catheters into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K901452 ↗
Decision Date
May 22, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The USCI R Access TM Introducer Set by C.R. Bard was cleared through the FDA 510(k) pathway on May 22, 1990. It is classified as a Class 2 device under product code DYB.
What It Is
The USCI R Access TM Introducer Set is designed to aid in the insertion of catheters into the vascular system. It typically includes a sheath, dilator, and guidewire, which together facilitate the smooth and safe introduction of catheters. This device is essential in procedures requiring vascular access, providing a stable and reliable entry point for further interventions.
Clinical Applications
This introducer set is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and other catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs and interventional suites. The device is used across various patient populations requiring vascular access for diagnostic or therapeutic purposes.
Indications for Use
The FDA indications suggest that this device is intended for use in facilitating the introduction of catheters into the vascular system. It is suitable for patients requiring vascular access for procedures like angiography or embolization.
Practical Considerations
The introducer set is available in various sizes to accommodate different catheter sizes and patient anatomies. Clinicians should ensure compatibility with the catheters intended for use and be familiar with the technique for insertion to minimize complications.
Frequently Asked Questions
What is USCI R Access TM Introducer Set used for?
It is used to facilitate the introduction of catheters into the vascular system for diagnostic and therapeutic procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during catheter-based procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters into the vascular system, suitable for angiography and embolization 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.