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needle fistula erika
Erika
Summary: The Needle Fistula Erika is a medical device used primarily in dialysis procedures to access arteriovenous fistulas. It is typically utilized by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K770382 ↗
Decision Date
March 8, 1977
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The Needle Fistula Erika was cleared through the FDA 510(k) pathway on March 8, 1977. Manufactured by Erika, it is classified as a Class 2 device under product code KOC.
What It Is
The Needle Fistula Erika is a specialized needle designed for accessing arteriovenous fistulas in patients undergoing hemodialysis. It facilitates efficient blood flow from the patient to the dialysis machine and back. The device is engineered to minimize trauma to the fistula site, which is crucial for maintaining long-term vascular access.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for patients with end-stage renal disease who require regular dialysis. Nephrologists and dialysis nurses use this needle to ensure safe and effective vascular access, which is critical for the dialysis process.
Indications for Use
The Needle Fistula Erika is indicated for use in patients who need vascular access for hemodialysis. It is specifically designed for accessing arteriovenous fistulas, which are surgically created connections between an artery and a vein.
Practical Considerations
The needle typically comes in various gauges to accommodate different patient needs and fistula sizes. It is important to use proper technique to minimize complications such as infiltration or hematoma. Compatibility with standard dialysis equipment is generally expected.
Frequently Asked Questions
What is Needle Fistula Erika used for?
It is used for accessing arteriovenous fistulas in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for vascular access in patients requiring hemodialysis, specifically for accessing 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.