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cadplan helios option 6 0
Varian Medical Systems
Summary: The CadPlan Helios Option 6 0 is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate dialysis treatment in patients with kidney failure.
FDA Clearance Information
Pathway
510K
Number
K984532 ↗
Decision Date
August 9, 1999
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The CadPlan Helios Option 6 0 was cleared through the FDA 510(k) pathway on August 9, 1999. Manufactured by Varian Medical Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The CadPlan Helios Option 6 0 is a specialized device designed to assist in the planning and execution of dialysis access procedures. It helps clinicians create precise access points for dialysis, ensuring optimal blood flow and minimizing complications. The device integrates advanced imaging and planning tools to enhance the accuracy and efficiency of the procedure.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients require long-term dialysis treatment. Nephrologists and vascular surgeons use it to establish and maintain vascular access in patients with chronic kidney disease. It is particularly beneficial in complex cases where standard access techniques may be challenging.
Indications for Use
The FDA indications suggest that the CadPlan Helios Option 6 0 is intended for use in creating and managing dialysis access points. It is suitable for patients with end-stage renal disease who require regular dialysis sessions.
Practical Considerations
Clinicians should consider the compatibility of the device with existing imaging systems and ensure proper training in its use. The device may come in various sizes to accommodate different patient anatomies, and its use requires careful planning to avoid complications.
Frequently Asked Questions
What is CadPlan Helios Option 6 0 used for?
It is used for planning and executing dialysis access procedures in patients requiring dialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for creating and managing dialysis access points in patients with end-stage renal disease.
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.