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subclavian hemodialysis cath w vitacuff device
Bd Becton Dickinson Vacutainer Systems Preanalytic
Summary: The Subclavian Hemodialysis Catheter with Vitacuff is a medical device used for vascular access in hemodialysis. It is primarily used by nephrologists and dialysis nurses to facilitate efficient dialysis treatment.
FDA Clearance Information
Pathway 510K
Number K884325 ↗
Decision Date April 25, 1989
Product Code FOZ
Device Class Class 2
Evidence 0 studies
The device was cleared through the FDA 510(k) pathway on April 25, 1989. Manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic, it is classified as a Class 2 device under product code FOZ.
What It Is
The Subclavian Hemodialysis Catheter with Vitacuff is a specialized catheter designed for insertion into the subclavian vein to provide vascular access for hemodialysis. The Vitacuff component is an antimicrobial cuff that helps reduce infection risk by providing a barrier against bacterial migration along the catheter. This device is crucial for patients requiring long-term dialysis access.
Clinical Applications
This catheter is commonly used in patients with chronic kidney disease who require regular hemodialysis. It is typically inserted by nephrologists or interventional radiologists in hospital settings or dialysis centers. The device is suitable for adult patients who need reliable and durable vascular access for ongoing dialysis treatments.
Indications for Use
The device is indicated for use in patients who need vascular access for hemodialysis. This includes individuals with end-stage renal disease or acute kidney injury requiring dialysis support.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and needs. It is important to follow aseptic techniques during insertion to minimize infection risk. The Vitacuff feature should be positioned correctly to maximize its antimicrobial benefits.
Frequently Asked Questions
What is the Subclavian Hemodialysis Cath w Vitacuff used for?
It is used for providing vascular access in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for vascular access in patients needing hemodialysis, such as those with chronic kidney disease.
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.