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medcomp 14 5f double lumen hemodialysis catheter
Medical Components
Summary: The medcomp 14 5f double lumen hemodialysis catheter is a device used for hemodialysis access. It is typically used by nephrologists and dialysis nurses for patients requiring dialysis.
FDA Clearance Information
Pathway 510K
Number K012562 ↗
Decision Date February 8, 2002
Product Code MSD
Device Class Class 2
Evidence 0 studies
The medcomp 14 5f double lumen hemodialysis catheter was cleared via the FDA 510k pathway on February 8, 2002. It is manufactured by Medical Components and classified as a Class 2 device.
What It Is
The medcomp 14 5f double lumen hemodialysis catheter is a vascular access device designed for hemodialysis. It consists of two lumens, allowing simultaneous arterial outflow and venous return. The catheter is inserted into a large vein, typically the internal jugular, subclavian, or femoral vein, providing a temporary solution for patients needing urgent or short-term dialysis access.
Clinical Applications
This catheter is commonly used in acute settings such as hospitals or dialysis centers for patients with chronic kidney disease or acute kidney injury who require dialysis. It is particularly useful in emergency situations where immediate dialysis access is necessary. Nephrologists, interventional radiologists, and dialysis nurses are the primary users of this device.
Indications for Use
The catheter is indicated for patients who need temporary vascular access for hemodialysis. It is suitable for those who are awaiting permanent access placement or have a malfunctioning permanent access.
Practical Considerations
The catheter typically comes in various lengths to accommodate different patient anatomies and is compatible with standard dialysis equipment. Proper insertion technique is crucial to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is medcomp 14 5f double lumen hemodialysis catheter used for?
It is used for providing temporary vascular access for hemodialysis in patients with kidney failure.
What specialties typically use this device?
Nephrologists, interventional radiologists, and dialysis nurses typically use this device.
What are the FDA-cleared indications?
The device is indicated for temporary vascular access in patients requiring hemodialysis.
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.