đź“‹ FDA Reference
Pediatric Two-Lumen Hemodialysis Catherization Kit
Arrow Intl.
Product: Arrow — all models and sizes
Summary: The pediatric two-lumen hemodialysis catheterization kit by Arrow Intl. is used for vascular access in pediatric patients requiring hemodialysis. It is primarily utilized by nephrologists and pediatric specialists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K984022 ↗
Decision Date ?
May 18, 1999
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on May 18, 1999, by Arrow Intl. It is classified as a Class 2 device under product code MPB.
What It Is
The pediatric two-lumen hemodialysis catheterization kit is designed to provide vascular access for hemodialysis in pediatric patients. It consists of a catheter with two lumens, allowing simultaneous removal and return of blood during dialysis. The kit typically includes necessary components for catheter insertion, ensuring sterile and efficient placement.
FDA-Cleared Indications
- Vascular access for hemodialysis in pediatric patients who require dialysis.
- Use as a non-implanted, two-lumen hemodialysis catheter placed in a central vein.
Clinical Applications
- Providing central venous access for hemodialysis in children with acute kidney failure.
- Providing central venous access for hemodialysis in children with chronic kidney failure.
- Withdrawing and returning blood during a hemodialysis treatment through separate catheter lumens.
- Placement in a central vein, such as the internal jugular or femoral vein, when appropriate for pediatric dialysis access.
Practical Considerations
- Select catheter length and diameter according to the child’s size, vascular anatomy, prescribed blood-flow requirements, and the manufacturer’s labeling.
- The device must be compatible with the dialysis circuit and used with sterile technique.
- Ultrasound and fluoroscopic or other appropriate imaging guidance may be used to support venous access and confirm catheter position.
- Potential complications include infection, bleeding, thrombosis, vessel injury, air embolism, and catheter malfunction.
- MRI safety depends on the exact catheter and any included components; verify the device-specific MRI labeling before scanning.
Frequently Asked Questions
What is the pediatric two-lumen hemodialysis catheterization kit used for?
It is used to provide vascular access for hemodialysis in pediatric patients with kidney failure.
What specialties typically use this device?
Pediatric nephrologists and intensivists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for pediatric patients requiring hemodialysis due to kidney failure.
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.