đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use with an arteriovenous fistula needle access site during hemodialysis.
- To protect the fistula needle and access site during dialysis treatment.
Clinical Applications
- Protecting an arteriovenous fistula needle insertion site during hemodialysis.
- Using over a dialysis needle access site in patients with a surgically created arteriovenous fistula.
- Helping shield the needle and access site from accidental contact or disturbance during a dialysis session.
Practical Considerations
- Use only with the fistula needle and dialysis access configuration specified in the device labeling.
- Select the appropriate size and ensure the protector does not compress the fistula, tubing, or needle.
- Apply using appropriate aseptic technique and inspect the access site regularly for bleeding, swelling, infiltration, or other complications.
- The FDA record provided does not establish MRI safety; consult the current manufacturer labeling before use in an MRI environment.
- Do not use as a substitute for monitoring the access site or securing the dialysis needle according to institutional protocol.
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.