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planone 1
Cosylab Jsc, Control System Laboratory
Summary: Planone 1 is a dialysis access device used to facilitate vascular access for dialysis patients. It is typically used by nephrologists and dialysis technicians.
FDA Clearance Information
Pathway
510K
Number
K250963 ↗
Decision Date
November 20, 2025
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Planone 1 was cleared through the FDA 510k pathway on November 20, 2025. It is manufactured by Cosylab Jsc and classified as a Class 2 device.
What It Is
Planone 1 is a medical device designed to aid in the creation and maintenance of vascular access for patients undergoing dialysis. It is part of the dialysis-access-devices category, which includes tools and equipment used to ensure effective and reliable access to the bloodstream. This device likely involves components that are compatible with standard dialysis equipment and is designed to minimize complications associated with vascular access.
Clinical Applications
Planone 1 is commonly used in nephrology and dialysis centers to provide reliable vascular access for patients requiring hemodialysis. It is particularly useful in settings where patients have challenging vascular anatomy or require long-term dialysis treatment. The device is suitable for adult and pediatric populations who need regular dialysis sessions.
Indications for Use
The FDA indications suggest that Planone 1 is intended for patients who require vascular access for dialysis treatment. This includes individuals with chronic kidney disease who need regular hemodialysis to manage their condition.
Practical Considerations
Planone 1 is likely available in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with existing dialysis machines and to follow proper insertion techniques to reduce the risk of infection or other complications.
Related Literature
The linked study focuses on the sex pheromone of the American cockroach, specifically the structure elucidation of periplanone-A. Although unrelated to the device, the study highlights the identification and synthesis of biologically active compounds. The key findings include the identification of periplanone B as a biologically active compound, but the study's limitations include its focus on entomology rather than medical devices.
Frequently Asked Questions
What is planone 1 used for?
Planone 1 is used to provide vascular access for patients undergoing dialysis treatment.
What specialties typically use this device?
Nephrologists and dialysis technicians typically use this device in dialysis centers.
What are the FDA-cleared indications?
Planone 1 is indicated for patients requiring vascular access for dialysis, such as 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.