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braun diacan r fistula needles
B. Braun Of America
Summary: The Braun Diacan R Fistula Needles are used for vascular access in hemodialysis. They are primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis sessions.
FDA Clearance Information
Pathway
510K
Number
K945850 ↗
Decision Date
October 6, 1995
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Braun Diacan R Fistula Needles were cleared through the FDA 510(k) pathway on October 6, 1995. Manufactured by B. Braun Of America, this device is classified as Class 2 under product code FIE.
What It Is
The Braun Diacan R Fistula Needles are specialized needles designed for creating vascular access in patients undergoing hemodialysis. These needles are essential for connecting the patient's bloodstream to the dialysis machine, allowing for the filtration of blood. The needles are typically used in pairs, with one needle drawing blood from the patient and the other returning filtered blood.
Clinical Applications
These needles are commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. They are crucial for patients with chronic kidney disease who require regular hemodialysis. The needles are used in patients with arteriovenous fistulas or grafts, which are surgically created connections between an artery and a vein.
Indications for Use
The FDA indications for the Braun Diacan R Fistula Needles include use in patients who need vascular access for hemodialysis. This typically involves patients with end-stage renal disease who require regular dialysis treatments.
Practical Considerations
The Braun Diacan R Fistula Needles come in various sizes to accommodate different patient anatomies and fistula types. They are designed for single-use to prevent infection and ensure sterility. Proper technique in needle insertion is crucial to minimize complications such as infiltration or hematoma.
Frequently Asked Questions
What is Braun Diacan R Fistula Needles used for?
They are used for vascular access in patients undergoing hemodialysis, facilitating blood flow to and from the dialysis machine.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use these needles in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The needles are indicated for use in patients requiring vascular access for hemodialysis, such as those 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.