📋 FDA Reference
Supercath a V Fistula
Summary: The Supercath A V Fistula is a medical device used for vascular access in hemodialysis patients. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis treatments.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K854773 ↗
Decision Date ?
April 8, 1986
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The Supercath A V Fistula was cleared through the FDA 510(k) pathway on April 8, 1986. Manufactured by Togo Medikit, it is classified as a Class 2 device under product code FIE.
What It Is
The Supercath A V Fistula is a specialized catheter designed for use in arteriovenous fistulas, which are surgically created connections between an artery and a vein. This device allows for repeated access to the bloodstream, which is essential for patients undergoing regular hemodialysis. Its design ensures durability and minimizes complications such as infection or clotting.
FDA-Cleared Indications
- Vascular access through an established arteriovenous fistula for hemodialysis.
- Repeated access to the bloodstream during hemodialysis treatments.
Clinical Applications
- Accessing a surgically created arteriovenous fistula during hemodialysis.
- Supporting blood removal from the patient for dialysis filtration.
- Supporting return of filtered blood to the patient during dialysis.
- Repeated vascular access in patients receiving ongoing hemodialysis.
Practical Considerations
- Select the device size and length according to the patient's anatomy and the location and depth of the arteriovenous fistula.
- Use aseptic technique and follow dialysis-unit protocols to reduce infection, bleeding, infiltration and thrombosis.
- Confirm compatibility with the dialysis tubing, bloodlines and other equipment before use; follow the manufacturer's instructions.
- Inspect the fistula and access site before and after use for adequate thrill or bruit, bleeding, hematoma, infection or impaired flow.
- The available FDA record does not establish MRI safety, device dwell time or a specific duration of use; consult current manufacturer labeling before MRI or prolonged placement.
Frequently Asked Questions
What is Supercath A V Fistula used for?
It is used for vascular access in patients undergoing hemodialysis, allowing efficient blood flow during treatment.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring long-term vascular access for hemodialysis, specifically those with arteriovenous fistulas.
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.