Edwards Lifesciences · Class II · Cleared Aug 29, 2025
| K-number | K252364 |
| Device name | Edwards eSheath Optima introducer set |
| Applicant | Edwards Lifesciences |
| Product code | DYB |
| Device class | Class II |
| Decision date | Aug 29, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
The Edwards eSheath Optima Introducer Set is a catheter introducer used to facilitate introduction and removal of compatible devices used with Edwards transcatheter heart valves into and from the vasculature. It consists of a sheath with a two-layer expandable design, vessel dilator, introducer, and in-sheath dilator, all available in 16 French diameter to accommodate 29mm Edwards THV systems.
The 16F device is identical to the 14F predicate sheath except for diameter scaling of the sheath, dilator, and introducer to accommodate the larger 29mm Edwards THV systems. Both versions feature the same elastomeric outer jacket for seamless expansion, introducer locking mechanism, optional in-sheath dilator, hydrophilic coating, radiopaque markers, and three-seal hemostasis housing with extension tube and stopcock.
Not stated in this summary.
The 16F Optima set is substantially equivalent to the 14F predicate device (K244046) because they share identical intended use (introduction and removal of compatible transcatheter heart valve devices) and the same core technological design and materials. The only difference is a proportional scaling of internal diameters to accommodate the larger 29mm valve system, which is a predictable engineering change that does not affect the fundamental performance or safety profile. Comprehensive testing confirmed equivalent performance across all critical parameters including hemostasis, kink resistance, tensile strength, biocompatibility, and thrombogenicity.
View the full FDA submission: accessdata.fda.gov