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pediatric two-lumen hemodialysis catherization kit
Arrow Intl.
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
510K
Number
K984022 ↗
Decision Date
May 18, 1999
Product Code
MPB
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.
Clinical Applications
This device is commonly used in pediatric nephrology for patients with acute or chronic kidney failure requiring dialysis. It is typically utilized in hospital settings, including pediatric intensive care units and dialysis centers. The catheter is inserted into a central vein, often the internal jugular or femoral vein, to facilitate efficient dialysis treatment.
Indications for Use
The device is indicated for pediatric patients who require hemodialysis due to kidney failure. It is suitable for both acute and chronic conditions where vascular access is necessary for dialysis treatment.
Practical Considerations
The catheter is available in various sizes to accommodate different pediatric patient needs. Clinicians should ensure compatibility with dialysis machines and follow proper insertion techniques to minimize complications such as infection or thrombosis.
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.