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sharghp a v fistula needle set
Shargh Pharmaceutical
Summary: The Sharghp A V Fistula Needle Set is used in hemodialysis for vascular access. Key evidence highlights its role in dialysis adequacy and potential for rare allergic reactions.
FDA Clearance Information
Pathway
510K
Number
K013384 ↗
Decision Date
January 7, 2002
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Sharghp A V Fistula Needle Set was cleared by the FDA through the 510(k) pathway on January 7, 2002. It is manufactured by Shargh Pharmaceutical and classified as a Class 2 device.
What It Is
The Sharghp A V Fistula Needle Set is designed for vascular access in hemodialysis patients. It facilitates efficient blood flow during dialysis sessions, essential for effective treatment.
Clinical Applications
Commonly used in hemodialysis settings, this needle set is crucial for patients requiring regular dialysis. It is employed to access arteriovenous fistulas, ensuring adequate blood flow for dialysis.
Evidence Summary
The literature includes 9 studies, ranging from case reports to systematic reviews, published between 2019 and 2025. These studies explore various aspects of needle use in dialysis, including technique and safety.
Reported Outcomes
Published studies report that the direction and distance of needle cannulation can impact dialysis adequacy, specifically KT/V and access recirculation. The choice of cannulation technique is also a focus of current research.
Safety Profile
Reported complications include rare cases of anaphylactic reactions during hemodialysis, as highlighted in a case report. The overall safety profile is consistent with typical risks associated with vascular access devices.
Evidence Limitations
The evidence base is limited by the small number of studies focusing on specific outcomes and safety profiles. Further research is needed to explore long-term efficacy and rare adverse events.
Frequently Asked Questions
What are the clinical indications for Sharghp A V Fistula Needle Set?
The device is indicated for vascular access in hemodialysis patients, facilitating blood flow during treatment.
What outcomes have been reported in clinical studies?
Studies report that needle direction and distance affect dialysis adequacy, with implications for KT/V and access recirculation.
What complications have been reported?
Safety data indicate rare anaphylactic reactions during hemodialysis, alongside typical vascular access risks.
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.