📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Accessing an arteriovenous fistula for hemodialysis.
- Establishing blood access between a surgically created artery-to-vein connection and the dialysis circuit.
Clinical Applications
- Arterial-side access of an arteriovenous fistula during hemodialysis.
- Venous-side access of an arteriovenous fistula during hemodialysis.
- Routine needle cannulation of a mature dialysis fistula in a dialysis center or hospital.
- Connecting fistula blood flow to standard hemodialysis tubing and equipment.
Practical Considerations
- The appropriate needle gauge and length depend on the fistula, prescribed blood-flow rate, access depth, and local dialysis protocol.
- Use sterile technique and proper cannulation technique to reduce bleeding, infiltration, hematoma, infection, and fistula injury.
- The needle must be compatible with the dialysis bloodline, connector, and equipment in use; compatibility should be confirmed before treatment.
- This is a needle-based device and is not itself an MRI implant. MRI safety depends on the needle material and whether the needle, tubing, or other components are present in the scanner; follow the device labeling and facility MRI policy.
- Do not use an arteriovenous fistula with signs of infection, thrombosis, inadequate maturation, severe bleeding, or other access complications unless directed by the treating clinician.
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.