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platypus av fistula needle protector avfnp
Itl Corporation Pty
Summary: The Platypus AV Fistula Needle Protector is a device used to protect arteriovenous fistula sites during dialysis. It is primarily used by nephrologists and dialysis technicians to ensure patient safety.
FDA Clearance Information
Pathway 510K
Number K991404 ↗
Decision Date May 14, 1999
Product Code FMI
Device Class Class 2
Evidence 0 studies
The Platypus AV Fistula Needle Protector was cleared via the FDA 510(k) pathway on May 14, 1999. Manufactured by ITL Corporation Pty, it is classified as a Class 2 device under product code FMI.
What It Is
The Platypus AV Fistula Needle Protector is designed to safeguard the needle access site of an arteriovenous fistula during dialysis treatments. It works by providing a physical barrier that helps prevent accidental dislodgement or trauma to the needle site. This device is essential in maintaining the integrity of the vascular access, which is crucial for effective dialysis therapy.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients undergo regular hemodialysis. Nephrologists, dialysis nurses, and technicians use it to protect the fistula site in patients with end-stage renal disease. It is particularly important in preventing complications such as bleeding or infection, which can occur if the needle is accidentally disturbed.
Indications for Use
The FDA indications suggest that this device is intended for use in patients who have an arteriovenous fistula for dialysis. It is used to protect the needle insertion site during and after dialysis sessions, reducing the risk of complications.
Practical Considerations
The Platypus AV Fistula Needle Protector is typically available in various sizes to accommodate different fistula sizes and patient needs. It is compatible with standard dialysis needles and should be applied following proper aseptic techniques to ensure patient safety.
Frequently Asked Questions
What is the Platypus AV Fistula Needle Protector used for?
It is used to protect the needle access site of an arteriovenous fistula during dialysis, preventing accidental dislodgement and trauma.
What specialties typically use this device?
Nephrology and dialysis centers commonly use this device, particularly by nephrologists, dialysis nurses, and technicians.
What are the FDA-cleared indications?
It is indicated for use in protecting the arteriovenous fistula needle site during dialysis to prevent complications such as bleeding or infection.
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.