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Hemo-Stream Hemodialysis Catheter Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K023847

by Rex Medical

Identifiers

510(k) Number
K023847 FDA 510(k)
FDA Product Code
MSD 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
SESK Substantially Equivalent — Kit FDA 510(k)

The Hemo-Stream Hemodialysis Catheter Set is a catheter, hemodialysis, implanted (per OpenFDA nomenclature), designed for vascular access in hemodialysis procedures. It provides dual-lumen functionality to simultaneously remove and return blood during treatment sessions, ensuring efficient dialysis exchange.

This set includes a 16F chronic, multilumen, radiopaque polyurethane catheter with a polyester cuff and two female luer-lock adapters. Supplied sterile and intended for single-use, it is classified as a Class 2 device under FDA product code MSD. The device received FDA 510(k) clearance (K023847) and adheres to regulation 876.5540, with no third-party review flagged.

Frequently asked questions

What is the primary purpose of the Hemo-Stream Hemodialysis Catheter Set, and how does its dual-lumen design benefit hemodialysis patients?

The Hemo-Stream Hemodialysis Catheter Set is designed for vascular access during hemodialysis procedures, allowing blood to be simultaneously removed and returned to the patient’s body. Its dual-lumen design ensures efficient blood flow, enabling continuous and effective dialysis exchange without the need for separate catheters for inflow and outflow.

Is the Hemo-Stream Hemodialysis Catheter Set intended for single-use or repeated use, and what materials is it made from?

The Hemo-Stream Hemodialysis Catheter Set is supplied sterile and intended for single-use only. It is constructed from radiopaque polyurethane with a polyester cuff, which helps secure the catheter in place within the body.

What sizes and features are included in this catheter set, and how does the radiopacity assist during placement?

The set includes a 16F chronic, multilumen catheter with two female luer-lock adapters for connecting dialysis tubing. The radiopaque material allows for clear visualization under X-ray or fluoroscopy during insertion, ensuring accurate and safe placement within the vascular system.

How should the Hemo-Stream Hemodialysis Catheter Set be stored, and are there any special handling instructions?

Since the set is sterile upon packaging, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer recommends following standard sterile field protocols when preparing for use, as it is intended for single-use only and should not be reused.

What regulatory pathway was followed for FDA clearance of this device, and how does this affect its use in clinical settings?

The Hemo-Stream Hemodialysis Catheter Set received FDA 510(k) clearance (K023847) under the traditional review pathway, adhering to regulation 876.5540. This clearance confirms that the device meets FDA safety and effectiveness standards for its intended use in hemodialysis vascular access, allowing clinicians to rely on its compliance with regulatory requirements.

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: Hemo-Stream Hemodialysis Catheter Set - Rex Medical | FDA Evidence Review, HEMO-STREAM HEMODIALYSIS CATHETER SET (K023847) — FDA 510(k) | Innolitics, 15 5f Hemo-Stream Hemodialysis Catheter Set - Rex Medical | FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rex Medical

Sources (1)

  • FDA 510(k) K023847 24 fields · synced Sep 19, 2026