Kaneka Americas Holding, Inc. · Class II · Cleared Jan 5, 2026
| K-number | K251668 |
| Device name | SurfRider 13 Microcatheter |
| Applicant | Kaneka Americas Holding, Inc. |
| Product code | QJP |
| Device class | Class II |
| Decision date | Jan 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The SurfRider 13 Microcatheter is a single-lumen microcatheter designed to deliver interventional devices such as embolic coils and diagnostic agents into blood vessels in the brain (neurovasculature). It features a metal-reinforced shaft with a hydrophilic coating, radiopaque markers for visualization, and comes in straight or pre-shaped tip configurations.
The device has a proximal outer diameter of 0.037 inches and distal of 0.022 inches, with a 165 cm effective length and 5 cm distal segment. It uses PTFE and Pebax shaft materials with stainless steel reinforcement, a PTFE inner liner, platinum-iridium marker bands, and a hydrophilic coating. It includes a shaping mandrel and introducer sheath and has a 36-month shelf life compared to the predicate's 12 months.
ISO 10993-1 for biocompatibility evaluation; ISO 10993 series testing including acute systemic toxicity (ISO 10993-11), cytotoxicity (ISO 10993-5), hemocompatibility (ISO 10993-4), and sensitization (ISO 10993-10). Sterilization validated to ISO 11135-1:2014 for ethylene oxide processing and residuals per ISO 10993-7:2008. Corrosion resistance per ISO 10555-1.
The SurfRider 13 has the same intended use, principle of operation, and similar technological characteristics as the predicate Phenom Catheters (K210230). Non-clinical bench testing and biocompatibility testing demonstrated that all differences in design do not raise new safety or effectiveness questions, and the device performs equivalent to the predicate and reference devices in all acceptance criteria.
View the full FDA submission: accessdata.fda.gov