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cordis cath sheath intro syst plus w unistasis val
Cordis
Summary: The Cordis Cath Sheath Intro System Plus with Unistasis Valve is a medical device used primarily in vascular procedures to facilitate the introduction of catheters. It is commonly used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K913801 ↗
Decision Date
October 16, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cordis Cath Sheath Intro System Plus with Unistasis Valve was cleared via the FDA 510k pathway on October 16, 1991. It is manufactured by Cordis and is classified as a Class 2 device.
What It Is
The Cordis Cath Sheath Intro System Plus with Unistasis Valve is a catheter sheath introducer system designed to provide a stable and secure entry point for catheters into the vascular system. The Unistasis valve helps to minimize blood loss and maintain hemostasis during catheter exchanges. This device is particularly useful in procedures requiring multiple catheter exchanges or prolonged vascular access.
Clinical Applications
This device is commonly used in interventional cardiology and radiology procedures, such as angiography, embolization, and other catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs. The device is used for patients requiring vascular access for diagnostic or therapeutic procedures, including those with cardiovascular conditions.
Indications for Use
The FDA indications for this device include its use in facilitating catheter introduction for vascular procedures. It is intended for patients who require catheter-based interventions for diagnostic or therapeutic purposes.
Practical Considerations
The Cordis Cath Sheath Intro System Plus is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the technique for sheath insertion and the use of the Unistasis valve to ensure optimal performance.
Frequently Asked Questions
What is the Cordis Cath Sheath Intro System Plus with Unistasis Valve used for?
It is used to facilitate the introduction of catheters into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in facilitating catheter introduction for vascular procedures in patients requiring diagnostic or therapeutic interventions.
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.