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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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA record identifies PrecisePlan 2 0 under product code MUJ for a dialysis vascular-access-related use.
- The available FDA summary does not state the specific procedure, anatomy, or performance claims for the device.
Clinical Applications
- Use in the labeled clinical setting for dialysis vascular-access care, as specified in the manufacturer's complete 510(k) labeling.
- Use by appropriately trained clinicians only according to the device's instructions for use and compatible procedural equipment.
Practical Considerations
- The publicly available summary is insufficient to confirm whether this is an access device, planning system, guide, catheter, imaging accessory, or another device type.
- Confirm the complete FDA-cleared labeling and instructions for use before describing specific procedures, access sites, sizes, or compatible equipment.
- Do not assume MRI safety, sterilization method, single-use status, or durability from the 510(k) classification alone; verify these details in the manufacturer's labeling.
- Evaluate compatibility with the imaging system and other procedural equipment before use.
- Use only by clinicians trained in dialysis vascular-access procedures and device-specific handling.
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.