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fresenius punctur-guard fistula needle sets
Fresenius Medical Care
Summary: The Fresenius Punctur-Guard Fistula Needle Sets are used in hemodialysis to access a patient's vascular system. They are primarily used by nephrologists and dialysis nurses in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K023162 ↗
Decision Date
March 20, 2003
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Fresenius Punctur-Guard Fistula Needle Sets were cleared via the FDA 510(k) pathway on March 20, 2003. Manufactured by Fresenius Medical Care, this device is classified as a Class 2 medical device.
What It Is
The Fresenius Punctur-Guard Fistula Needle Sets are specialized needles designed for vascular access in hemodialysis patients. These needles feature a safety mechanism to reduce the risk of needlestick injuries. The device is integral in facilitating efficient and safe blood flow between the patient and dialysis machine, ensuring effective treatment.
Clinical Applications
These needle sets are commonly used in dialysis centers and hospitals during hemodialysis sessions. They are essential for patients with chronic kidney disease requiring regular dialysis. Nephrologists and dialysis nurses use these needles to access arteriovenous fistulas or grafts, which are surgically created connections between an artery and a vein.
Indications for Use
The FDA-cleared indications for this device are for use in patients requiring vascular access for hemodialysis. It is specifically designed for accessing arteriovenous fistulas or grafts in patients undergoing regular dialysis treatment.
Practical Considerations
The needle sets come in various sizes to accommodate different patient anatomies and fistula types. Compatibility with standard dialysis equipment is ensured, and clinicians should be trained in proper cannulation techniques to minimize complications.
Frequently Asked Questions
What is Fresenius Punctur-Guard Fistula Needle Sets used for?
They are used for vascular access in hemodialysis patients, allowing blood to be efficiently drawn and returned during dialysis sessions.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients undergoing hemodialysis, specifically for use 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.