Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
A PVC catheter is a urinary catheter whose tube is made of medical-grade polyvinyl chloride. PVC names the material, not a separate kind of device: in the United States, catheters of this kind are regulated as urological catheters under 21 CFR 876.5130, Class II. Clinic staff, buyers and students who need to read a product listing or an FDA clearance for a PVC catheter will find below what the term covers, what a coating on one is, and which specifications a real clearance document states.
Who handles it: clinics and facilities that stock catheters, and the buyers and students who read their listings and clearances.
What a PVC catheter is
FDA defines a urological catheter 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(a), checked 2026-10-30). A PVC catheter is one of these devices made from polyvinyl chloride. One FDA clearance summary, FDA 510(k) K212567 (clearance letter dated 7 December 2022, checked 2026-10-30), describes its device as a single-use urinary catheter consisting of a “disposable PVC (medical grade) catheter” designed for clean intermittent catheterization and drainage of the bladder.
How it is built: tube, connector and coating
The same summary describes a PVC tube with a hydrophilic polymer coating. Its performance testing covered flow rate, strength of the catheter, connector security and coefficients of friction. Biocompatibility testing followed ISO 10993-1:2009, including cytotoxicity (ISO 10993-5:2009), irritation and sensitization (ISO 10993-10:2010) and subacute toxicity (ISO 10993-11:2017).
What the coating is
In that summary the coating contains polyvinyl pyrrolidone (PVP), “a kind of hydrophilic polymer, which binds the water molecules to the surface of the catheter to reduce the risk of friction” during use. The coating is activated by water, supplied with or without a water sachet. A coating is therefore a surface layer applied to the tube; it is a separate attribute from the tube material, so a product listing needs to name both. For a gel-lubricated, ready-to-use variant see the guide to the pre-lubricated catheter.
Types and variants
21 CFR 876.5130 groups catheters by function and design, not by material. Its identification paragraph names these types within the generic device, so “PVC” or “polyurethane” does not change the regulation a product falls under.
| Type named in 21 CFR 876.5130(a) | What the regulation says | Source |
|---|---|---|
| Straight catheters | Included in the generic device type | 21 CFR 876.5130(a) |
| Urethral catheters | Included in the generic device type | 21 CFR 876.5130(a) |
| Coudé catheters | Included in the generic device type | 21 CFR 876.5130(a) |
| Balloon retention type catheters | Included in the generic device type | 21 CFR 876.5130(a) |
| Ureteral catheters | Included in the generic device type | 21 CFR 876.5130(a) |
| Hydrophilic-coated PVC intermittent catheter | Example device cleared under this regulation, Class II, product code EZD | FDA 510(k) K212567 |
For how materials such as latex, silicone and PVC and coated versus uncoated catheters are compared in practice, read the urinary catheter types and selection guide.
Sizes and specifications that matter
The table gives the values stated for one cleared device. They describe that product, not every PVC catheter.
| Specification | Value stated | Source |
|---|---|---|
| Tube material | Disposable PVC (medical grade) | FDA 510(k) K212567 |
| Coating | Hydrophilic polymer containing polyvinyl pyrrolidone (PVP), water-activated | FDA 510(k) K212567 |
| Size range | French (Fr) 8 to 18 | FDA 510(k) K212567 |
| Availability | Male and female versions | FDA 510(k) K212567 |
| Use pattern | Single use; clean intermittent catheterization | FDA 510(k) K212567 |
| Stated indication | Patients with chronic urine retention | FDA 510(k) K212567 |
| FDA classification | Class II; 21 CFR 876.5130; product code EZD | FDA 510(k) K212567; 21 CFR 876.5130(b)(1) |
What to check on a product listing
These points are stated in the cleared example and are the ones a listing or instructions for use should state:
- Intended use and indication. A clearance states what the device is indicated for; the example is labelled for clean intermittent catheterization in patients with chronic urine retention.
- Single use or not. The example device is labelled single use.
- Size and sex-specific versions. Sizes are given in French units; the example spans Fr 8 to 18 in male and female versions.
- Regulatory status. Urological catheters are Class II under 21 CFR 876.5130. Only the accessories listed in 876.5130(b)(2), such as ureteral stylets and adapters, are Class I.
- Tube material and coating. A listing should name both.
Clinical questions are outside this page and belong with a clinician.
Labelling and handling
- A device labelled single use is not designed for reuse.
- Follow the manufacturer’s storage and handling statements on the packaging and instructions for use.
Common mistakes
- Treating “PVC” as a device category. The regulation and product code are set by the device type and intended use, not the tube material.
- Treating tube material and coating as the same thing. In the example, PVC is the tube and PVP-based hydrophilic polymer is the coating.
- Generalising one product’s sizes. Fr 8 to 18 is the range stated for one cleared device, not a rule for all PVC catheters.
- Ignoring the labelling. Sizes, coating and indication are product-specific and stated on the product’s own labelling.
What polyurethane is in a catheter
Polyurethane is a plastic family, and TPU (thermoplastic polyurethane) is the form most often named for catheter tubing: a polyurethane that can be melted and shaped by extrusion or injection molding. One manufacturer, Covestro, describes its Texin RxT70A resin as “an aromatic polyether-based thermoplastic polyurethane” that “can be processed by injection molding or extrusion” and lists catheters and catheter balloons, specialty tubing and connectors among its typical medical applications (Covestro, Texin RxT70A product page, checked 2026-10-31). The same page says the product “may be suitable for certain medical application” and that limited applications need prior written approval from Covestro, so the resin is a raw material and the finished catheter is what FDA evaluates. A tube material is not a regulatory category: 21 CFR 876.5130 describes urological catheters by function and design, so a polyurethane catheter and a PVC catheter are both classified by what the device is and is used for. For the material in detail see what TPU is and what a thermoplastic elastomer is.
What PTFE is and where it appears on catheters
PTFE is polytetrafluoroethylene, a fluoropolymer. It is not the coating in the PVC example above, which uses a PVP-based hydrophilic polymer. FDA’s guidance on intravascular catheters, wires and delivery systems with lubricious coatings (October 2019) says such devices often have hydrophilic and/or hydrophobic lubricious coatings, naming “polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone” as examples (FDA guidance, Lubricious Coatings Labeling Considerations, checked 2026-10-31). That guidance covers intravascular devices, not urinary catheters, so it shows only that PTFE is a recognised lubricious coating material; a urinary catheter’s labelling states its own tube and coating. PTFE also exists as a solid material: FDA describes a nonabsorbable suture as a “monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE” (21 CFR 878.5035, checked 2026-10-31); see the PTFE suture guide.
TPU vs PVC: what the sources state
The sources give no ranking of the two materials, and none is made here. The table lists only what each source states.
| Question | PVC catheter | TPU (polyurethane) catheter | Source |
|---|---|---|---|
| Example material statement | “Disposable PVC (medical grade)” tube in a cleared hydrophilic-coated intermittent catheter | “Aromatic polyether-based thermoplastic polyurethane” resin, with catheters and catheter balloons among typical applications | FDA 510(k) K212567; Covestro Texin RxT70A |
| FDA regulation of the catheter | 21 CFR 876.5130, Class II | 21 CFR 876.5130 describes the device by function and design, not by material | 21 CFR 876.5130 |
| Plasticizer | FDA has issued a public health notification titled “PVC Devices Containing the Plasticizer DEHP” (2002) | The Covestro page describes this resin as “plasticizer free” | FDA notification; Covestro page |
| What the labelling states | Tube material, coating, size, single use | Grade, tube material, coating, size, single use | FDA 510(k) K212567 |
Both names describe a tube material, not a finished product: a product listing should name the tube material, any coating and the intended use, and the instructions for use are the source for a specific catheter. The TPE vs TPU comparison covers the polyurethane side of the family.
Frequently asked questions
What is a PVC catheter?
A urinary catheter whose tube is made of medical-grade polyvinyl chloride. FDA regulates urological catheters as a Class II device under 21 CFR 876.5130.
Does a polyurethane catheter fall under a different FDA regulation than a PVC catheter?
21 CFR 876.5130 describes urological catheters by function and design (straight, coudé, balloon retention, ureteral and others) and does not divide them by material, so material alone does not move a urological catheter to a different section of that regulation. Which section applies to a given product depends on its intended use and design.
What is a catheter coating?
A surface layer on the tube. In the cleared example it is a hydrophilic polymer containing polyvinyl pyrrolidone (PVP) that binds water to the surface to reduce friction and is water-activated.
Is a PTFE-coated catheter the same as a hydrophilic-coated PVC catheter?
Not necessarily. “PTFE-coated” names one coating material, while the cleared example described above uses a PVP-based hydrophilic coating on a PVC tube. No primary source on PTFE-coated catheters is cited on this page, so check a product’s labelling for the exact tube material and coating it states.
What sizes do PVC catheters come in?
Catheter sizes are given in French units. The cleared example above is supplied in Fr 8 to 18; other products state their own ranges.
What is polyurethane?
A plastic family. Its thermoplastic form, TPU, can be melted and shaped by extrusion or injection molding; Covestro lists catheters, catheter balloons and tubing among typical medical uses of one TPU resin. See what TPU is.
What is PTFE?
PTFE is polytetrafluoroethylene, a fluoropolymer. FDA’s lubricious-coatings guidance names it, with PVP and silicone, as an example coating on intravascular devices, and FDA regulates expanded PTFE (ePTFE) suture under 21 CFR 878.5035. The cleared PVC urinary catheter example on this page uses a PVP-based coating, not PTFE.
What is the difference between TPU and PVC?
Both are tube materials. The cleared example here is a medical-grade PVC tube; Covestro describes a TPU resin used for catheters and tubing. FDA regulates urological catheters by function under 21 CFR 876.5130 whichever material is used, and FDA has a public health notification on PVC devices containing the plasticizer DEHP. The product’s own labelling states its material.
Catheters and related supplies are listed in the catheters, urology and incontinence category. For the polyurethane material in general, see what TPU is. Related reading: the drainage catheters institutional stocking guide.
Sources
- eCFR, 21 CFR 876.5130, Urological catheter and accessories: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5130 (checked 2026-10-30).
- U.S. FDA, 510(k) summary and clearance letter K212567, PVC Hydrophilic Urethral Catheter: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212567.pdf (checked 2026-10-30).
- Covestro, Texin RxT70A thermoplastic polyurethane product page: https://solutions.covestro.com/en/products/texin/texin-rxt70a_83773112-14493894 (checked 2026-10-31).
- U.S. FDA, Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations (October 2019): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/intravascular-catheters-wires-and-delivery-systems-lubricious-coatings-labeling-considerations (checked 2026-10-31).
- Cornell LII, 21 CFR 878.5035, Nonabsorbable expanded polytetrafluoroethylene surgical suture: https://www.law.cornell.edu/cfr/text/21/878.5035 (checked 2026-10-31).
- U.S. FDA, Public Health Notification: PVC Devices Containing the Plasticizer DEHP (2002, archived copy): https://webharvest.gov/peth04/20041015194019/http://www.fda.gov/cdrh/safety/dehp.pdf (checked 2026-10-31).
