📋 FDA Reference
Usci R Access Tm Introducer Set
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitation of the introduction of catheters into the vascular system.
Clinical Applications
- Providing vascular access for angiography and other catheter-based imaging procedures.
- Providing access for embolization procedures.
- Maintaining a stable entry pathway for catheters during interventional procedures.
- Supporting vascular catheter placement in catheterization laboratories and interventional suites.
Practical Considerations
- Select the sheath and dilator size to match the catheter system and the target vessel.
- Confirm compatibility among the introducer sheath, dilator, guidewire, and catheter before use.
- Insertion is generally performed using imaging guidance and standard sterile vascular-access technique.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and contrast-related complications from the associated procedure.
- MRI safety depends on the specific components and materials. Verify the current product labeling before MRI exposure; do not assume the set is MRI safe or MRI conditional.
Procedures that use this device
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.