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A V Fistula Needle Set 351
Sorensen Research
Summary: The a v fistula needle set 351 by Sorensen Research is used in dialysis access procedures. It is FDA 510k cleared and supported by 15 studies. Key evidence highlights its role in maintaining vascular access patency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K771492 ↗
Decision Date ?
August 16, 1977
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The a v fistula needle set 351 was cleared through the FDA 510k pathway on August 16, 1977. Manufactured by Sorensen Research, it is classified as a Class 2 device.
What It Is
The a v fistula needle set 351 is designed for use in hemodialysis procedures, facilitating access to arteriovenous fistulas. It is intended to ensure reliable vascular access for dialysis treatment.
FDA-Cleared Indications
- Accessing an established arteriovenous fistula for hemodialysis.
- Providing vascular access for the removal and return of blood during dialysis treatment.
Clinical Applications
- Needle access to an arteriovenous fistula before hemodialysis.
- Withdrawal of blood from a dialysis fistula.
- Return of treated blood to a dialysis fistula.
- Routine vascular access during maintenance hemodialysis.
Evidence Summary
The literature includes 15 studies, ranging from 2015 to 2024, encompassing various study types such as RCTs and prospective cohorts. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the a v fistula needle set 351 is effective in maintaining vascular access patency, with some studies highlighting its role in early detection of access dysfunction. The device is associated with improved outcomes in dialysis access management.
Safety Profile
Reported complications include needle-related injuries and venous needle dislodgement, which can lead to significant clinical concerns. Safety data emphasize the need for careful monitoring during use.
Evidence Limitations
Current evidence is limited by the variability in study designs and the need for larger, multicenter trials to validate findings. Further research is needed to explore long-term outcomes and optimize usage protocols.
Practical Considerations
- The needle size, length and configuration must match the fistula, dialysis prescription and facility protocol.
- Use requires an adequately matured fistula and trained dialysis personnel; it is not intended to create vascular access.
- Inspect the sterile package and device before use, and follow the manufacturer's instructions for insertion, connection and disposal.
- MRI safety depends on the specific needle and any metallic components. The device should not be taken into the MRI environment unless its labeling identifies it as MR Safe or MR Conditional.
- Potential complications include infiltration, bleeding, hematoma, infection, thrombosis and injury to the fistula; avoid use when the access site is clinically unsuitable.
Frequently Asked Questions
What are the clinical indications for a v fistula needle set 351?
The device is indicated for use in hemodialysis procedures to maintain vascular access through arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access patency and early detection of access dysfunction.
What complications have been reported?
Safety data indicate complications such as needle-related injuries and venous needle dislodgement.
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.