| K-number | K260993 |
| Device name | Amplatzer TorqVue Delivery System |
| Applicant | Abbott |
| Product code | DQY |
| Device class | Class II |
| Decision date | Apr 24, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The Amplatzer TorqVue Delivery System is a catheter delivery sheath designed to provide a pathway through which devices are introduced within the heart chambers, coronary vasculature, or peripheral vasculature. It is available in 45° or 180° curve configurations with usable sheath lengths of 60 cm or 80 cm.
The device incorporates substantially equivalent design, function, packaging, sterilization process, materials, and operating principles to the predicate. Key differences exist in the hemostasis valve component, including removal of an adapter, geometry updates, and material changes, while other components (sheath, dilator, delivery cable, loader, cable vise) remain identical.
ISO 10993-1 (Biological evaluation of medical devices), ISO 14971 (Risk management), ASTM F2475 (Biocompatibility), ISO 11135 (Sterilization by ethylene oxide), ASTM F2825, ASTM D4332, and ASTM D4169 (Packaging), and the FDA guidance on International Standard ISO 10993-1 (2023).
The subject device is substantially equivalent to the predicate Amplatzer TorqVue Delivery System (K072313) because it maintains the same intended use, design characteristics, fundamental technology, and operating principles. All biocompatibility, design verification, sterilization, and packaging testing met acceptance criteria, demonstrating that the hemostasis valve changes do not alter the device's safety or effectiveness.
View the full FDA submission: accessdata.fda.gov