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the bellco fistula needles
Bellco Artifidial Organ Spec.
Summary: The Bellco Fistula Needles are used in dialysis to access the bloodstream. They are primarily used by nephrologists and dialysis nurses for patients requiring hemodialysis.
FDA Clearance Information
Pathway
510K
Number
K801632 ↗
Decision Date
August 4, 1980
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Bellco Fistula Needles were cleared through the FDA 510(k) pathway on August 4, 1980. Manufactured by Bellco Artifidial Organ Spec., they are classified as Class 2 medical devices.
What It Is
The Bellco Fistula Needles are specialized needles designed for vascular access in patients undergoing hemodialysis. They are used to connect the patient's circulatory system to the dialysis machine, allowing for the filtration of blood. These needles are typically designed to minimize discomfort and reduce the risk of complications such as infiltration or infection.
Clinical Applications
These needles are commonly used in dialysis centers and hospitals for patients with chronic kidney disease requiring regular hemodialysis. They are essential in creating a reliable vascular access point, typically through an arteriovenous fistula or graft. Nephrologists and dialysis nurses frequently use these devices in both outpatient and inpatient settings.
Indications for Use
The Bellco Fistula Needles are indicated for use in patients who need hemodialysis, particularly those with established arteriovenous fistulas or grafts. They are suitable for patients with chronic kidney disease who require regular blood filtration.
Practical Considerations
These needles come in various sizes to accommodate different patient anatomies and access sites. Compatibility with standard dialysis machines is ensured, and proper technique is crucial to prevent complications. Clinicians should be trained in vascular access techniques to optimize patient outcomes.
Frequently Asked Questions
What is Bellco Fistula Needles used for?
The Bellco Fistula Needles are used for vascular access in hemodialysis, allowing blood to be filtered through a dialysis machine.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use these devices in the management of patients requiring hemodialysis.
What are the FDA-cleared indications?
The needles are indicated for use in patients needing hemodialysis, particularly those with arteriovenous fistulas or grafts.
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.