đź“‹ FDA Reference
xplan 2 2 with the body system
Radionics, A Division Of Tyco Healthcare Group Lp
Summary: The xplan 2 2 with the body system is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate efficient dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K013661 ↗
Decision Date
December 3, 2001
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The xplan 2 2 with the body system was cleared through the FDA 510(k) pathway on December 3, 2001. Manufactured by Radionics, a division of Tyco Healthcare Group LP, it is classified as a Class 2 device under product code MUJ.
What It Is
The xplan 2 2 with the body system is a specialized medical device designed to assist in the creation and maintenance of vascular access for dialysis patients. It is engineered to support the precise placement and management of dialysis access devices, ensuring optimal blood flow and reducing complications. The device integrates advanced technology to enhance procedural accuracy and patient safety.
Clinical Applications
This device is commonly used in clinical settings such as hospitals and dialysis centers. Nephrologists and vascular surgeons employ it during procedures to establish or maintain arteriovenous fistulas or grafts for patients requiring regular dialysis. It is particularly beneficial for patients with chronic kidney disease who need reliable and long-term vascular access.
Indications for Use
The xplan 2 2 with the body system is indicated for use in patients requiring dialysis access. It is suitable for individuals with end-stage renal disease or chronic kidney conditions that necessitate regular dialysis treatments.
Practical Considerations
Clinicians should consider the compatibility of the xplan 2 2 with existing dialysis systems and ensure proper sizing for individual patient anatomy. Familiarity with the device's operational technique is essential for optimal outcomes and minimizing procedural risks.
Frequently Asked Questions
What is xplan 2 2 with the body system used for?
It is used to assist in the creation and maintenance of vascular access for dialysis patients.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring dialysis access, particularly those with chronic kidney 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.