The US schedule specifically carves out rubber catheters into their own line (9018390020), while catheters made of other materials — such as silicone, polyurethane, or PVC — fall under 9018390030 or 9018390040 depending on whether they are classified with bougies and sondes. The material composition of the catheter body is therefore the primary classification criterion, and importers should document the material in commercial invoices and technical specifications to support the correct subheading.

Most catheters and cannulae are classified as Class II medical devices requiring 510(k) premarket notification, though some higher-risk devices (such as certain intravascular catheters) may require PMA. A limited number of low-risk device types may qualify for 510(k) exemption, but importers should verify the specific device's FDA classification and regulatory pathway before assuming exemption applies. All imported medical devices must come from FDA-registered foreign establishments, and CBP coordinates with FDA to flag non-compliant shipments for examination or detention.