| K-number | K260091 |
| Device name | Aventus Introducer Sheath |
| Applicant | Inquis Medical |
| Product code | DYB |
| Device class | Class II |
| Decision date | Apr 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
The Aventus Introducer Sheath is a single-use catheter device inserted into blood vessels to provide a conduit for placing endovascular devices while minimizing blood loss. It features a user-actuatable hemostasis valve, a stainless steel reinforced shaft with hydrophilic coating, a radiopaque distal tip, and a flexible tapered dilator for smooth insertion over a 0.035-inch guidewire.
Both the Aventus and predicate Gore DrySeal Flex devices are single-patient-use, large-bore introducer sheaths with user-operated hemostasis valves. Both use stainless steel-reinforced polymeric jackets with lubricious liners, radiopaque distal features, stopcocks for side port fluid control, flexible tapered dilators, and hydrophilic external coatings on the introducer shaft.
ISO 10993-1:2018 (biocompatibility), ISO 14937:2009 (sterilization validation), AAMI TIR28:2016(R)2020 (sterilization), USP <85> and AAMI ST72 (bacterial endotoxin testing). No software, electrical safety, or animal testing was conducted.
The Aventus Introducer Sheath is substantially equivalent to the predicate Gore DrySeal Flex device because both share identical intended use, indications for use, and technological characteristics including the same materials, design features, hemostasis mechanism, and manufacturing methods. Performance testing demonstrated the Aventus meets all physical, functional, biocompatibility, and sterilization requirements equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov