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14 fr two-lumen hemodialysis catherization kit with blue flextip arrowg ard blue catheter for high volume infusions pro
Arrow Intl.
Summary: The 14 fr two-lumen hemodialysis catheter by Arrow Intl. is used for high-volume infusions in dialysis. It is typically utilized by nephrologists and other healthcare professionals in dialysis centers and hospitals.
FDA Clearance Information
Pathway
510K
Number
K993933 ↗
Decision Date
September 14, 2000
Product Code
MPB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on September 14, 2000. Manufactured by Arrow Intl., it is classified as a Class 2 device under product code MPB.
What It Is
The 14 fr two-lumen hemodialysis catheter is a medical device designed for high-volume blood infusions and dialysis. It features a blue flextip for ease of insertion and reduced trauma to the vessel. The catheter is part of a kit that includes necessary components for catheterization, facilitating efficient and safe vascular access.
Clinical Applications
This catheter is commonly used in hemodialysis procedures, particularly for patients with chronic kidney disease requiring regular dialysis. It is typically employed in hospital settings, dialysis centers, and sometimes in home dialysis setups. Nephrologists and dialysis nurses are the primary users, focusing on adult and pediatric patients needing reliable vascular access.
Indications for Use
The FDA indications suggest this device is intended for patients needing high-volume blood infusions, such as those undergoing hemodialysis. It is suitable for patients with compromised kidney function requiring regular dialysis treatments.
Practical Considerations
The 14 fr size is typical for adult patients, providing a balance between flow rate and vessel size compatibility. The blue flextip design aids in reducing insertion trauma, and the kit includes components that ensure compatibility with standard dialysis equipment.
Frequently Asked Questions
What is the 14 fr two-lumen hemodialysis catheter used for?
It is used for high-volume blood infusions in hemodialysis, providing reliable vascular access for patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for patients needing high-volume blood infusions, such as those undergoing 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.