Medisystems Hemodialysis Fistula Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K910734 FDA 510(k)
- FDA Product Code
- FIE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5540 FDA 510(k)
- Regulation Number
- 876.5540 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medisystems Hemodialysis Fistula Set is a sterile, single-use vascular access device designed for hemodialysis procedures. It includes needles and associated tubing to establish temporary connections between a patient’s arteriovenous fistula and the dialysis machine, facilitating blood flow for filtration and return during treatment. This set supports reliable vascular access, a critical component for patients with end-stage renal disease requiring regular dialysis sessions.
The set is supplied as a sterile, single-pack or twin-pack configuration, intended for one-time use per patient. It is regulated under FDA 510(k) clearance (K910734) and falls under product code FIE, adhering to regulatory standards for hemodialysis accessories. Needle gauges and lengths (e.g., 15G x 1” or 16G x 1”) are specified for compatibility with arteriovenous fistulas, with some variants featuring rotatable hubs and protective guards. Storage and handling must comply with sterile medical device protocols to ensure patient safety.
Frequently asked questions
What is the Medisystems Hemodialysis Fistula Set used for?
The Medisystems Hemodialysis Fistula Set is designed to establish temporary vascular access during hemodialysis procedures. It connects a patient’s arteriovenous fistula to the dialysis machine, enabling controlled blood flow for filtration and return. This is essential for patients with end-stage renal disease requiring regular dialysis sessions, as reliable vascular access reduces complications and ensures effective treatment.
How is the Medisystems Hemodialysis Fistula Set supplied, and is it reusable?
The set is supplied in sterile, single-pack or twin-pack configurations, each intended for one-time use only per patient. This design minimizes infection risks and ensures compliance with sterile medical device protocols. Reuse is not recommended or supported, as it could compromise sterility and patient safety.
What needle sizes and features are included in this fistula set?
The set includes needles with standardized gauges and lengths, such as 15G x 1” or 16G x 1”, optimized for compatibility with arteriovenous fistulas. Some variants feature rotatable hubs and protective guards to enhance usability and reduce needle-related complications during dialysis. These specifications are tailored to improve vascular access reliability.
How should the Medisystems Hemodialysis Fistula Set be stored?
Storage must adhere to strict sterile medical device protocols to preserve integrity. The set should be kept in its original, unopened packaging in a clean, dry environment, protected from direct sunlight, moisture, and extreme temperatures. Follow manufacturer guidelines to prevent contamination and ensure readiness for immediate use when needed.
What regulatory clearance does this device hold, and how does it ensure safety?
The Medisystems Hemodialysis Fistula Set holds FDA 510(k) clearance (K910734) under product code FIE, indicating it meets regulatory standards for hemodialysis accessories. This clearance confirms the device’s safety and effectiveness for its intended use, including compliance with design controls, performance testing, and clinical validation. The set is also classified as Class II, reflecting its role in critical patient care.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: medisystems hemodialysis fistula set, MEDISYSTEMS HEMODIALYSIS FISTULA SET (K910734) — FDA 510 (k) | Innolitics, MEDISYSTEMS CORPORATION D9-7006MG Medisystems Hemodialysis Fistula ..., MEDISYSTEMS CORPORATION D9-6005MGP Medisystems TwinPack Hemodialysis ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K910734 | Class II | Active |
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Manufacturer
- Manufacturer
- Medisystems Corp.
Sources (1)
- FDA 510(k) K910734 24 fields · synced Oct 1, 2026