đź“‹ FDA Reference
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 ?
510(k)
Number ?
K884325 ↗
Decision Date ?
April 25, 1989
Product Code ?
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients who require dialysis treatment.
- Temporary central venous access for extracorporeal blood processing when indicated by the device labeling.
Clinical Applications
- Hemodialysis access for patients with acute kidney injury who need temporary dialysis support.
- Hemodialysis access for patients with end-stage kidney disease when a short-term catheter is required.
- Central venous access during dialysis treatment when a subclavian approach is selected.
Practical Considerations
- The catheter is intended for short-term intravascular use, generally less than 30 days under the listed FDA product classification; the exact dwell time depends on the device labeling and clinical judgment.
- Insertion requires sterile technique and image guidance may be used to confirm venous access and catheter position.
- The Vitacuff should be positioned according to the manufacturer's instructions; it is not a substitute for catheter-site care and infection-prevention protocols.
- Subclavian access can be associated with central venous stenosis, which may affect future hemodialysis access planning; the access site should be selected with the patient's long-term vascular plan in mind.
- MRI safety is device-specific. Confirm the exact catheter model and current manufacturer labeling before MRI; do not assume the device is MR Safe or MR Conditional.
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.