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Vivamed Fistula Needle
S.S. Ent.
Summary: The Vivamed Fistula Needle is a medical device used in hemodialysis to access the patient's bloodstream. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K903440 ↗
Decision Date ?
April 20, 1992
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The Vivamed Fistula Needle was cleared through the FDA 510k pathway on April 20, 1992. It is manufactured by S.S. Ent. and classified as a Class 2 device under product code FIE.
What It Is
The Vivamed Fistula Needle is a specialized needle designed for use in hemodialysis procedures. It is used to create a vascular access point by puncturing a fistula, which is a surgically created connection between an artery and a vein. This device facilitates the efficient transfer of blood to and from the dialysis machine, allowing for the removal of waste products from the bloodstream.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients with an arteriovenous fistula.
- Needle access to the bloodstream during hemodialysis treatment.
Clinical Applications
- Cannulation of a surgically created arteriovenous fistula for hemodialysis.
- Establishing access for blood removal and return during a dialysis session.
- Repeated access in patients receiving ongoing hemodialysis through an arteriovenous fistula.
Practical Considerations
- The device is available in different needle sizes; selection should match the fistula, prescribed dialysis blood flow, patient anatomy and facility protocol.
- It is intended for use with standard hemodialysis blood tubing and equipment.
- Insertion requires trained dialysis personnel and careful assessment of the fistula to reduce infiltration, hematoma, bleeding and loss of access function.
- The FDA record and provided labeling do not establish MRI safety; MRI conditions should be confirmed with the current product labeling or manufacturer before scanning.
- Use should be avoided or modified when the fistula is immature, infected, thrombosed or otherwise unsuitable for cannulation, based on clinical assessment.
Frequently Asked Questions
What is the Vivamed Fistula Needle used for?
It is used to access the bloodstream in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses in dialysis centers and hospitals.
What are the FDA-cleared indications?
For creating vascular access in hemodialysis patients with end-stage renal disease.
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.