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This page describes products and general use; it is not medical advice.
A hemodialysis catheter is a flexible tube placed in a blood vessel to give a dialysis machine access to a patient’s blood. Under US federal rules it belongs to the “blood access device” family, and the version meant to stay in place for 30 days or more is a prescription, Class II device. This guide is for clinic staff, buyers and students who need the product class, the regulatory definition and the labeling requirements in one place.
Who uses it: dialysis nurses and technicians, vascular access teams, and the staff who stock dialysis units and home-training programs.
What a hemodialysis catheter is
The FDA regulation for blood access devices (21 CFR 876.5540) identifies the device class as one “intended to provide access to a patient’s blood for hemodialysis or other chronic uses.” It covers implanted and nonimplanted devices and their accessories. Blood leaves and returns through the catheter to the dialysis machine, via blood tubing.
It is a specialised relative of the central venous catheter, and it is a different product from a fistula needle or a peritoneal dialysis catheter.
How it is built
The regulation describes the implanted type as flexible or rigid tubes, such as catheters or cannulae, that are surgically implanted in blood vessels, “may come through the skin” and are intended to remain in the body for 30 days or more. Its examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The regulation also notes that these devices may contain coatings or additives that add functionality.
Its special controls require that components that contact the body be shown to be biocompatible, with material names and designation numbers provided. They list performance tests including pressure versus flow rates for the arterial and venous lumens, recirculation rates, priming volumes, tensile testing of joints and materials, air and liquid leakage testing, and testing of repeated clamping of the catheter extensions that simulates use over the life of the device, with retesting for leakage.
Types: how FDA separates them
| Type | Intended time in the body | Examples named in the regulation | FDA class |
|---|---|---|---|
| Implanted blood access device | 30 days or more; prescription device | Single and double lumen catheters with cuff(s); fully subcutaneous port-catheter systems; A-V shunt cannulae | Class II (special controls) |
| Nonimplanted blood access device | Less than 30 days | Fistula needles; single needle dialysis sets (coaxial flow needle and alternating flow needle) | Class II (performance standards) |
| Accessories common to either type | Not applicable | Shunt adaptor, shunt connector, shunt stabilizer, vessel dilator, shunt guard, fistula adaptor, declotting tray | Class II (performance standards) |
| Certain accessories | Not applicable | Cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, joint ring | Class I |
Source for every row: 21 CFR 876.5540, paragraphs (a) and (b), checked 2026-10-31.
Labeling, materials and compatibility
For implanted hemodialysis devices the regulation requires labeling that gives arterial and venous pressure versus flow rates, the forward and reverse recirculation rates, the arterial and venous priming volumes, and an expiration date. The labeling must identify any disinfecting agents that cannot be used to clean components of the device. Contraindicated disinfecting agents, where the material is incompatible with them, must be identified by a warning printed on the catheter or, alternatively, by a label affixed to the patient’s medical record with written instructions provided to the patient. The labeling must also include a patient implant card.
Devices that include subcutaneous ports must also carry labeling with the recommended type of needle for access.
Related supply guides
For supply planning see the home hemodialysis training checklist, the outpatient dialysis center checklist and the guide to disinfecting caps.
FAQ
What is a hemodialysis catheter used for?
It gives dialysis equipment access to a patient’s blood for hemodialysis, as defined in 21 CFR 876.5540.
How does FDA classify a hemodialysis catheter?
The implanted blood access device, intended to remain 30 days or more, is Class II with special controls; the nonimplanted type is Class II under performance standards.
What is the difference between implanted and nonimplanted blood access devices?
The regulation separates them by intended time in the body: 30 days or more for the implanted type, less than 30 days for the nonimplanted type.
How are incompatible disinfectants identified?
Through a warning printed on the catheter, or a label affixed to the patient’s medical record with written instructions given to the patient, as required for implanted devices under 21 CFR 876.5540(b)(1)(v).
Sources
- U.S. FDA / eCFR, 21 CFR 876.5540 Blood access device and accessories, https://www.ecfr.gov/current/title-21/section-876.5540, checked 2026-10-31.
