Disposable Hemodialysis Access Catheter Sets
Foshan Nanhai Bai He Medical Technology
Product: Disposable Hemodialysis Access Catheter Set — all models and sizes
FDA Clearance Information
The disposable hemodialysis access catheter sets by Foshan Nanhai Bai He Medical Technology were cleared through the FDA 510k pathway on November 18, 2011. They are classified as Class 2 devices under product code MPB.
What It Is
FDA-Cleared Indications
- Temporary vascular access for hemodialysis in patients with kidney failure.
- Hemodialysis access when a permanent arteriovenous fistula or graft is not available or cannot be used.
Clinical Applications
- Providing temporary central venous access for hemodialysis.
- Initiating urgent or immediate hemodialysis when permanent access is unavailable.
- Providing dialysis access while an arteriovenous fistula or graft is being created or matures.
- Providing temporary dialysis access during hospitalization or outpatient dialysis treatment.
Practical Considerations
- Catheter sets are available in different lengths and configurations; selection depends on patient anatomy, access vein, flow requirements and dialysis equipment.
- Common access veins include the internal jugular and femoral veins; subclavian access is generally avoided when possible because central venous stenosis can compromise future dialysis access.
- Insertion is typically performed using ultrasound and fluoroscopic or other imaging guidance, with sterile technique and local anesthesia with or without moderate sedation.
- These are single-use devices and should be connected only to compatible dialysis tubing and equipment according to the manufacturer’s instructions.
- MRI safety depends on the specific catheter materials and labeling. The exact product’s MRI conditions should be confirmed before scanning; the catheter should not be assumed to be MRI safe.
Frequently Asked Questions
What is disposable hemodialysis access catheter sets used for?
They are used to provide temporary vascular access for patients undergoing hemodialysis, facilitating blood filtration.
What specialties typically use this device?
Nephrologists and dialysis nurses in hospital settings or outpatient dialysis clinics typically use these devices.
What are the FDA-cleared indications?
The device is indicated for temporary vascular access in patients requiring hemodialysis, particularly those without permanent access sites.