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super c hemodialysis apheresis chronic catheter model dc-36 series dc-40 series dc-45 series
Horizon Medical Products
Summary: The Super C Hemodialysis Apheresis Catheter is a chronic catheter used for hemodialysis and apheresis procedures. It is typically used by nephrologists and dialysis specialists for patients requiring long-term vascular access.
FDA Clearance Information
Pathway
510K
Number
K011916 ↗
Decision Date
October 31, 2001
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Super C Hemodialysis Apheresis Catheter was cleared through the FDA 510k pathway on October 31, 2001. Manufactured by Horizon Medical Products, it is classified as a Class 2 device under product code MSD.
What It Is
The Super C Hemodialysis Apheresis Catheter is a medical device designed for long-term vascular access in patients undergoing hemodialysis or apheresis. It consists of a flexible tube inserted into a large vein, allowing for efficient blood flow during treatments. The catheter is available in multiple series (dc-36, dc-40, dc-45), offering different lengths and configurations to suit patient needs.
Clinical Applications
This catheter is commonly used in nephrology and hematology settings, particularly for patients with chronic kidney disease requiring regular hemodialysis or those undergoing therapeutic apheresis. It is typically placed in hospital or outpatient settings by trained specialists. The device is suitable for adult and pediatric patients who need reliable long-term vascular access.
Indications for Use
The FDA-cleared indications for this catheter include providing vascular access for patients needing hemodialysis or apheresis. It is intended for individuals with conditions that necessitate repeated blood purification procedures.
Practical Considerations
The catheter 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. Clinicians should be familiar with the specific series used to ensure optimal patient outcomes.
Frequently Asked Questions
What is the Super C Hemodialysis Apheresis Catheter used for?
It is used for providing long-term vascular access in patients undergoing hemodialysis or apheresis.
What specialties typically use this device?
Nephrologists and dialysis specialists typically use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The catheter is indicated for vascular access in patients requiring hemodialysis or apheresis treatments.
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.