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preciseplan 2 0
Precision Therapy Intl.
Summary: The preciseplan 2 0 is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to plan and execute precise interventions for dialysis patients.
FDA Clearance Information
Pathway
510K
Number
K022411 ↗
Decision Date
September 20, 2002
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The preciseplan 2 0 was cleared through the FDA 510(k) pathway on September 20, 2002. Manufactured by Precision Therapy Intl., it is classified as a Class 2 device under product code MUJ.
What It Is
The preciseplan 2 0 is a specialized device designed to assist in the planning and execution of dialysis access procedures. It provides clinicians with detailed imaging and guidance to optimize the placement and maintenance of vascular access for dialysis. The device integrates with existing imaging systems to enhance precision and reduce complications during procedures.
Clinical Applications
This device is commonly used in settings where dialysis access is created or maintained, such as hospitals and specialized dialysis centers. Nephrologists and vascular surgeons use it to ensure accurate placement of arteriovenous fistulas or grafts. It is particularly beneficial for patients with challenging vascular anatomy or those requiring repeated access interventions.
Indications for Use
The preciseplan 2 0 is indicated for use in patients requiring dialysis access, particularly those needing precise planning and execution of vascular access procedures. It is suitable for patients with chronic kidney disease who are undergoing regular dialysis treatments.
Practical Considerations
Clinicians should be aware of the device's compatibility with existing imaging systems and ensure proper training for optimal use. The device may come in various sizes to accommodate different patient anatomies, and careful technique is necessary to maximize its benefits.
Frequently Asked Questions
What is preciseplan 2 0 used for?
The preciseplan 2 0 is used for planning and executing dialysis access procedures, ensuring precise placement of vascular access points.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in hospital and dialysis center settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring dialysis access, aiding in the precise planning and execution of vascular access procedures.
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.