📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for hemodialysis.
Clinical Applications
- Accessing the bloodstream during hemodialysis.
- Connecting vascular access to the extracorporeal dialysis circuit.
- Withdrawing blood for filtration during a dialysis session.
- Returning filtered blood to the patient during hemodialysis.
Practical Considerations
- Use the size and configuration specified in the product labeling and selected for the patient's vascular anatomy and dialysis circuit.
- The set is intended for use with compatible hemodialysis equipment and should be handled by trained dialysis or clinical personnel.
- Potential complications of vascular access include bleeding, hematoma, infection, thrombosis, infiltration and accidental dislodgement.
- MRI safety depends on the specific components and materials. Confirm the current manufacturer labeling before MRI; do not assume the set is MR safe or MR conditional.
- The set is generally a single-use, procedure-specific product. It is not a permanent vascular access, and replacement depends on the access method, component integrity and clinical need.
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.