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This page describes products and general use; it is not medical advice.
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Quick answer: a urinary balloon (Foley) catheter is a flexible tube with two separate channels, called lumens. One lumen is open at both ends and drains urine into a collection bag. The other lumen has a valve at its outside end and connects to a balloon at the tip. The tube then joins the drainage bag through a funnel connector. This guide names each part as a manufacturer’s instructions for use (IFU) describes it, covers types, materials and label symbols, and explains how the parts are classified by the FDA. It is written for clinic staff, buyers and students who need to read a catheter label or specification with confidence.
What are the parts of a catheter?
“Catheter” covers many device families (urinary, intravenous, dialysis, epidural). This page maps the urinary balloon catheter, because that is the design people usually mean when they search for the parts of a Foley catheter. For another family, see hemodialysis catheters. For the Foley itself, the closest single-topic reference is what is a Foley catheter.
The U.S. FDA identifies a urological catheter and accessories as “a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract” (21 CFR 876.5130, checked 2026-11-01). Its list of device types includes balloon retention type catheters and straight catheters, which is why a balloon is a feature of some urinary catheters and not of all of them.
Parts of a Foley catheter
The table follows one manufacturer’s published IFU (Mais India Foley Balloon Catheter, edition 02, revision dated 20.05.2026, checked 2026-11-01). Other makers may name or build parts differently, so read the IFU that comes with the product you hold.
| Part | What the IFU says |
|---|---|
| Tube (shaft) | A flexible tube made of latex (siliconised) or silicone, depending on the variant. |
| Drainage lumen | One lumen is open at both ends and lets urine drain out into a collection bag. |
| Balloon lumen and valve | The other lumen has a valve on the outside end and connects to a balloon at the tip. The IFU lists a non-return valve made of PP, stainless steel and silicone. |
| Balloon (tip) | Described in the IFU as the part that holds the catheter in place and stops it slipping out. |
| Sleeve | Listed as a separate component, made of PVC sheet. |
| Funnel connector | A A universal funnel connector that joins the catheter to the urine bag. |
The lumen layout is the main thing to understand. See catheter lumens for how lumen count differs across catheter designs, and catheter balloon sizes for the balloon.
Types and variants
| Variant | Difference | Source |
|---|---|---|
| 2-way Foley | Listed in the IFU as a type; the IFU describes the two-lumen design above. | Mais India IFU, checked 2026-11-01 |
| 3-way Foley | Listed in the IFU as a second type. The same IFU lists bladder irrigation among the product’s indications. See 3-way Foley catheters for the third channel. | Mais India IFU, checked 2026-11-01 |
| Latex (siliconised) | Latex material; the IFU lists latex allergy among warnings and potential side effects. | Mais India IFU, checked 2026-11-01 |
| Silicone | Silicone material variant of the same product line. | Mais India IFU, checked 2026-11-01 |
Sizes that matter
The IFU states that sizes are measured in French units (Fr). Check the size printed on the pack against the product specification.
Which parts to check on the label and pack
This is a checklist of items the IFU names, tied to the parts above. It is not a procedure.
- Tube: the IFU says to inspect for visible defects such as kinks or leaks before use.
- Package and date: check the expiration date and that the packaging is intact; the IFU says not to use the device if the package is damaged or the date has passed.
- Label symbols: the IFU’s symbol key includes latex and latex-free, do-not-re-use, do-not-re-sterilise and ethylene oxide sterilisation symbols. Read the latex symbol on the pack to see which variant you hold.
- Funnel connector: the IFU names a universal funnel connector as the part that joins the catheter to the urine bag. See types of catheter bags for the bag end.
Handling and labelling basics
- The IFU is for use by trained healthcare professionals; the intended user is a qualified doctor or paramedic.
- It is a single-use sterile product and should not be reprocessed or re-sterilised.
- The IFU gives short-term use, less than 30 days, and warns that prolonged use of the latex version may lead to catheter-associated urinary tract infection.
FDA classification of catheter parts
Under 21 CFR 876.5130, urological catheters and accessories are Class II (performance standards). Class I applies to the ureteral stylet (guidewire), the stylet for a gastrourological catheter, and the ureteral catheter adapter, connector and holder. Those Class I items are exempt from premarket notification, subject to the limits in 21 CFR 876.9 (checked 2026-11-01). In practice, the catheter itself and some of its accessories sit in different classes.
Common mistakes
- Treating all catheters as having a balloon. The FDA’s own list separates balloon retention type catheters from straight catheters.
- Assuming a latex-free product from the family name. The IFU lists latex and silicone variants of the same product, so check the symbol.
- Ignoring a damaged pack or a passed expiry date. The IFU says not to use the device in either case.
FAQ
What is the balloon port for?
In the IFU’s description, the second lumen has a valve at its outside end and connects to the balloon at the tip, which holds the catheter in place.
How many lumens does a Foley catheter have?
The IFU describes a two-lumen design: one for drainage and one for the balloon. It also lists a 3-way type; see 3-way Foley catheters.
What are the parts of a Foley catheter?
Tube, drainage lumen, balloon lumen with valve, balloon, sleeve and funnel connector, as named in the table above.
Is a catheter regulated by the FDA?
Yes. Urological catheters and accessories are identified in 21 CFR 876.5130 and classified as Class II, with some accessories Class I.
Sources
- Mais India Medical Devices, Foley Balloon Catheter IFU, edition 02, rev. 02 (20.05.2026): maisindia.com IFU PDF, checked 2026-11-01. One manufacturer’s document, not a universal specification.
- U.S. FDA, 21 CFR 876.5130 Urological catheter and accessories: law.cornell.edu/cfr/text/21/876.5130, checked 2026-11-01.
