đź“‹ FDA Reference
cath sheath introducer syst plus w unistasis valve
Cordis
Summary: The cath sheath introducer system with unistasis valve is a medical device used primarily in vascular procedures to facilitate the insertion of catheters. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K911794 ↗
Decision Date
July 19, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The cath sheath introducer system was cleared through the FDA 510(k) pathway on July 19, 1991. Manufactured by Cordis, it is classified as a Class 2 medical device under product code DYB.
What It Is
The cath sheath introducer system is a medical device designed to aid in the insertion of catheters into blood vessels. It features an introducer sheath with an integrated unistasis valve that helps maintain hemostasis during catheter exchanges. This device is essential in procedures requiring vascular access, providing a stable and secure entry point for various catheter-based interventions.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and other catheter-based interventions. It is particularly useful in settings where repeated catheter exchanges are necessary, such as in the treatment of vascular diseases or during diagnostic imaging. The device is suitable for adult patients requiring vascular access.
Indications for Use
The FDA indications for this device include its use in facilitating the insertion and exchange of catheters in vascular procedures. It is intended for patients requiring vascular access for diagnostic or therapeutic interventions.
Practical Considerations
The cath sheath introducer system is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with standard catheterization techniques and may require specific training for optimal use. Clinicians should ensure proper sizing to minimize vascular trauma.
Frequently Asked Questions
What is the cath sheath introducer system used for?
It is used to facilitate the insertion and exchange of catheters in vascular procedures.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating catheter insertion and exchange during vascular 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.