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argyle a-v medi-wing hemodialysis set
Sherwood Medical
Summary: The Argyle A-V Medi-Wing Hemodialysis Set is a medical device used for vascular access in hemodialysis. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood filtration in patients with renal failure.
FDA Clearance Information
Pathway
510K
Number
K801618 ↗
Decision Date
August 13, 1980
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Argyle A-V Medi-Wing Hemodialysis Set was cleared through the FDA 510(k) pathway on August 13, 1980. Manufactured by Sherwood Medical, it is classified as a Class 2 device under product code FIE.
What It Is
The Argyle A-V Medi-Wing Hemodialysis Set is a vascular access device designed for use in hemodialysis. It enables the connection between the patient's circulatory system and the dialysis machine, allowing for the removal and return of blood during treatment. The device typically includes components such as needles, tubing, and wings to secure the device in place, facilitating efficient and safe dialysis sessions.
Clinical Applications
This device is commonly used in nephrology and dialysis centers, where patients with chronic kidney disease undergo regular hemodialysis. It is particularly useful in settings requiring repeated vascular access, such as outpatient dialysis clinics and hospitals. The device is suitable for adult and pediatric patients who require ongoing dialysis treatment.
Indications for Use
The Argyle A-V Medi-Wing Hemodialysis Set is indicated for patients requiring vascular access for hemodialysis. It is suitable for individuals with end-stage renal disease or acute kidney injury who need regular dialysis to manage their condition.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard dialysis machines and is designed for ease of use, with features that promote secure placement and minimize patient discomfort during insertion and use.
Frequently Asked Questions
What is the Argyle A-V Medi-Wing Hemodialysis Set used for?
It is used for vascular access in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients requiring hemodialysis, such as those with 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.