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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
510K
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.
Clinical Applications
This device is commonly used in dialysis centers and hospitals, where patients with chronic kidney disease undergo regular hemodialysis treatments. Nephrologists and dialysis nurses typically use the Vivamed Fistula Needle to establish vascular access in patients with arteriovenous fistulas. It is crucial for patients who require long-term dialysis, ensuring effective and repeated access to the bloodstream.
Indications for Use
The FDA-cleared indications for the Vivamed Fistula Needle include its use in creating vascular access for hemodialysis patients. It is intended for patients with end-stage renal disease who require regular dialysis treatments.
Practical Considerations
The Vivamed Fistula Needle is available in various sizes to accommodate different patient anatomies and fistula types. It is compatible with standard dialysis equipment and requires careful technique to minimize complications such as infiltration or hematoma formation.
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.