📋 FDA Reference
Tops Dispos Infusion Set Hemodialysis
Top Surgical Manufacturers
Summary: The tops dispos infusion set hemodialysis is a medical device used in hemodialysis procedures to facilitate vascular access. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K841119 ↗
Decision Date ?
April 20, 1984
Product Code ?
KNZ
Device Class ?
Class 2
Evidence ?
0 studies
The tops dispos infusion set hemodialysis was cleared through the FDA 510(k) pathway on April 20, 1984. Manufactured by Top Surgical Manufacturers, it is classified as a Class 2 device under product code KNZ.
What It Is
The tops dispos infusion set hemodialysis is a disposable medical device designed for use in hemodialysis, a procedure to filter waste and excess fluids from the blood when the kidneys are not functioning properly. The device typically includes components such as needles and tubing that connect to the dialysis machine, ensuring safe and efficient blood flow during treatment. Its disposable nature helps reduce the risk of infection and cross-contamination.
FDA-Cleared Indications
- Use during hemodialysis for patients requiring extracorporeal blood treatment because of renal failure.
- Establish and maintain the blood circuit between the patient's vascular access and the hemodialysis equipment during treatment.
Clinical Applications
- Connecting a hemodialysis machine to a patient's vascular access during routine dialysis.
- Supporting blood withdrawal and return during hemodialysis.
- Use in dialysis centers or hospitals for patients receiving intermittent hemodialysis.
- Use with an appropriate arteriovenous fistula, arteriovenous graft, or dialysis catheter according to the product labeling and facility protocol.
Practical Considerations
- Confirm that the set's needle, tubing, connectors, and blood-flow specifications are appropriate for the patient's access and prescribed dialysis treatment.
- Verify compatibility with the dialysis machine and other components of the extracorporeal circuit before use.
- Use sterile technique and follow institutional protocols for connection, monitoring, disconnection, and disposal to reduce infection, air embolism, bleeding, and clotting risks.
- Inspect the package and components for damage, leaks, or loss of sterility; this is a disposable device and should not be reused.
- MRI safety is not established from the available record. Keep the set and associated equipment away from the MRI environment unless the complete configuration has been evaluated and labeled for MRI use.
Frequently Asked Questions
What is tops dispos infusion set hemodialysis used for?
It is used to facilitate vascular access during hemodialysis procedures for patients with kidney failure.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis due to renal failure.
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.