ABBOTT MEDICAL · Class II · Cleared Mar 13, 2026
| K-number | K260499 |
| Device name | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 |
| Applicant | ABBOTT MEDICAL |
| Product code | DQY |
| Device class | Class II |
| Decision date | Mar 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The Amplatzer Trevisio Intravascular Delivery System is a catheter delivery sheath designed to deliver various Amplatzer Occluders (devices used to treat heart defects) by providing a pathway through which these devices are introduced into the heart chambers, coronary vasculature, or peripheral blood vessels. It is a single-use, sterile device provided via ethylene oxide gas sterilization.
The subject device incorporates substantially equivalent design, function, packaging, sterilization process, materials, and operating principles as the predicate (K190581). Key differences are limited to the hemostasis valve component, which includes removal of an adapter, geometry updates, and material changes. All other components—sheath, dilator, delivery cable, loader, and cable vise—are identical to the predicate.
ISO 10993-1 (biocompatibility evaluation), ISO 14971 (risk management), ASTM F2475 (biocompatibility), ISO 11135 (ethylene oxide sterilization), ASTM F2825, ASTM D4332, and ASTM D4169 (packaging verification). Non-clinical bench testing covered dimensional, system leak, tensile strength, and Luer compliance specifications.
View the full FDA submission: accessdata.fda.gov