đź“‹ FDA Reference
render-plan 3-d 4 00 precise-plan 1 0
Precision Therapy Intl.
Summary: The render-plan 3-d 4 00 precise-plan 1 0 is a medical device used in dialysis access procedures. It is typically utilized by nephrologists and vascular surgeons to plan and execute precise interventions.
FDA Clearance Information
Pathway
510K
Number
K002240 ↗
Decision Date
August 23, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 23, 2000, by Precision Therapy Intl. It is classified as a Class 2 device under product code MUJ.
What It Is
The render-plan 3-d 4 00 precise-plan 1 0 is a sophisticated 3D planning tool designed for dialysis access procedures. It enables clinicians to visualize and plan vascular access with high precision, improving outcomes and reducing procedural risks. The device integrates advanced imaging techniques to provide detailed anatomical insights.
Clinical Applications
This device is commonly used in nephrology and vascular surgery settings, particularly for patients requiring dialysis access. It is beneficial in preoperative planning, allowing for detailed mapping of vascular structures. The device is used in hospitals and specialized clinics, aiding in both initial access creation and revision surgeries.
Indications for Use
The device is indicated for use in planning dialysis access procedures. It is suitable for patients who require vascular access for hemodialysis, helping clinicians to optimize the placement and longevity of access points.
Practical Considerations
The device is compatible with standard imaging systems and requires minimal setup time. Clinicians should ensure proper calibration for accurate 3D rendering. It is available in various configurations to accommodate different patient anatomies.
Frequently Asked Questions
What is render-plan 3-d 4 00 precise-plan 1 0 used for?
It is used for planning and executing dialysis access procedures with high precision.
What specialties typically use this device?
Nephrologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for planning dialysis access procedures, particularly for patients needing vascular access for 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.