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plume fistula needle
Hospal Medical
Summary: The plume fistula needle is a medical device used for vascular access in dialysis procedures. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow during hemodialysis.
FDA Clearance Information
Pathway
510K
Number
K841791 ↗
Decision Date
July 9, 1984
Product Code
FIQ
Device Class
Class 2
Evidence
0 studies
The plume fistula needle was cleared through the FDA 510(k) pathway on July 9, 1984. Manufactured by Hospal Medical, it is classified as a Class 2 device under product code FIQ.
What It Is
The plume fistula needle is a specialized needle designed for use in dialysis procedures. It is used to access arteriovenous fistulas, which are surgically created connections between an artery and a vein. This device allows for efficient blood flow from the patient to the dialysis machine and back, ensuring effective filtration and waste removal from the bloodstream.
Clinical Applications
Commonly used in dialysis centers and hospitals, the plume fistula needle is essential for patients undergoing hemodialysis. Nephrologists and dialysis nurses use this device to ensure stable and reliable vascular access. It is particularly important for patients with chronic kidney disease who require regular dialysis sessions to manage their condition.
Indications for Use
The FDA indications for the plume fistula needle involve its use in accessing arteriovenous fistulas for dialysis. It is intended for patients with end-stage renal disease who need regular hemodialysis treatments.
Practical Considerations
The plume fistula needle is available in various sizes to accommodate different patient needs and fistula characteristics. Compatibility with standard dialysis machines is ensured, and proper technique in needle insertion is crucial to minimize complications such as infiltration or hematoma.
Frequently Asked Questions
What is the plume fistula needle used for?
It is used for vascular access in hemodialysis, allowing blood to flow to and from the dialysis machine.
What specialties typically use this device?
Nephrology and dialysis nursing are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for use in accessing arteriovenous fistulas for patients undergoing hemodialysis.
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.