đź“‹ FDA Reference
Medcomp 14 5f Double Lumen Hemodialysis Catheter
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 ?
510(k)
Number ?
K012562 ↗
Decision Date ?
February 8, 2002
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Temporary vascular access for hemodialysis.
- Access for patients who require dialysis while awaiting placement or maturation of permanent vascular access.
- Access for patients whose existing permanent dialysis access is unavailable or malfunctioning.
Clinical Applications
- Providing short-term hemodialysis access in patients with acute kidney injury.
- Providing temporary dialysis access for patients with chronic kidney disease who need hemodialysis before permanent access is available.
- Providing urgent dialysis access in a hospital or dialysis setting.
- Connecting the patient to standard hemodialysis equipment through separate arterial and venous lumens.
Practical Considerations
- The catheter is available in different lengths to accommodate patient anatomy and the selected venous access site.
- Common insertion sites include the internal jugular, subclavian, and femoral veins; site selection depends on the clinical situation and preservation of future permanent dialysis access.
- Insertion should be performed using appropriate sterile technique and imaging guidance when indicated to reduce complications such as bleeding, malposition, thrombosis, and infection.
- The catheter should be used only with compatible dialysis equipment and according to the product instructions for use.
- MRI safety depends on the specific catheter materials and labeling; the exact product instructions should be checked before MRI. Do not assume that every catheter is MR safe or MR conditional.
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.