đź“Š Evidence-Based Reference
top single use u t w a-v fistula needle y type
Top Surgical Manufacturers
Summary: The Top Single Use U T W A-V Fistula Needle Y Type is a single-use device designed for vascular access in dialysis. It is FDA 510k cleared and primarily used in dialysis-access procedures. Current evidence includes 5 studies, though none directly address this device.
FDA Clearance Information
Pathway
510K
Number
K844343 ↗
Decision Date
January 8, 1985
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on January 8, 1985, by Top Surgical Manufacturers. It is classified as a Class 2 device under product code FIE.
What It Is
The Top Single Use U T W A-V Fistula Needle Y Type is a medical device used to establish vascular access for hemodialysis. It is designed for single use to minimize infection risk and ensure patient safety.
Clinical Applications
This device is commonly used in clinical settings for patients requiring hemodialysis, particularly those with arteriovenous fistulas. It facilitates efficient and safe blood access for dialysis treatment.
Evidence Summary
The available literature includes 5 studies, though none specifically evaluate this device. The studies cover various medical conditions and treatments, indicating a need for direct research on this needle.
Reported Outcomes
Published studies report no direct efficacy findings related to the Top Single Use U T W A-V Fistula Needle Y Type. The studies provided do not focus on dialysis-access devices, highlighting a gap in specific outcome data.
Safety Profile
Reported complications include no specific safety data for the Top Single Use U T W A-V Fistula Needle Y Type, as the linked studies do not address this device. Further research is needed to establish a safety profile.
Evidence Limitations
The current evidence lacks direct studies on the Top Single Use U T W A-V Fistula Needle Y Type, limiting conclusions on its efficacy and safety. Future research should focus on device-specific outcomes and complications.
Frequently Asked Questions
What are the clinical indications for Top Single Use U T W A-V Fistula Needle Y Type?
The device is indicated for vascular access in patients undergoing hemodialysis, particularly those with arteriovenous fistulas.
What outcomes have been reported in clinical studies?
No specific outcomes for this device have been reported in the provided studies, indicating a need for targeted research.
What complications have been reported?
The provided evidence does not report specific complications for this device, highlighting a gap in safety data.
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.