📋 FDA Reference
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 ?
510(k)
Number ?
K011916 ↗
Decision Date ?
October 31, 2001
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Vascular access for apheresis procedures.
Clinical Applications
- Repeated hemodialysis treatments in patients who require chronic vascular access.
- Therapeutic apheresis procedures that require access for blood removal and return.
- Use with compatible dialysis or apheresis equipment through the catheter lumens.
Practical Considerations
- The catheter is available in DC-36, DC-40 and DC-45 series; the appropriate length and configuration depend on patient anatomy and the intended access site.
- Placement is generally performed by a trained clinician using sterile technique and imaging guidance when appropriate, with the catheter positioned in a large central vein.
- The catheter must be connected only to compatible dialysis or apheresis equipment and managed according to the manufacturer's instructions.
- Important complications include bloodstream infection, catheter malfunction, thrombosis, bleeding, vessel injury and air embolism.
- MRI safety is not established by the information provided here. The device labeling and current manufacturer instructions should be checked before MRI, and the catheter should not be assumed to be MRI safe.
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.