Aventus Thrombectomy System (IM-2100)

The Aventus Thrombectomy System is a catheter-based manual aspiration device designed to remove blood clots (emboli and thrombi) from peripheral blood vessels without surgery. It can also inject, infuse, or aspirate contrast media and other fluids into or from blood vessels. The system consists of a thrombectomy catheter with embedded sensors, a 60-cc manual syringe, and a clot canister, and is intended for single use only.

The subject device (model IM-2100) is modified from the predicate (model IM-2200) by reducing the catheter diameter and updating the software algorithm to account for this dimensional change. Both devices share core technological features: single-patient-use large-bore aspiration catheters with a 60-cc manual syringe, disposable powered electronics and embedded software, stainless steel-reinforced polymeric shafts with variable stiffness, radiopaque distal tip markings, and stopcocks for fluid flow direction.

ISO 10993-1:2018 (biocompatibility), ISO 14937:2009 (sterilization characterization), USP <85> and AAMI ST72 (bacterial endotoxin testing), IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 62366-1 (electrical safety and EMC), 21 CFR Part 58 (GLP animal testing), and FDA Guidance documents on device software and animal studies.

The intended use and indications for use are identical to the predicate device (K250202). The subject device maintains the same fundamental technological design: both are manual aspiration catheter systems with identical component compositions, materials, sterilization methods, and biocompatibility profiles. The two modifications—catheter diameter reduction and corresponding software algorithm refinement—are minor design variations that maintain functional equivalence while potentially improving clinical utility. Comprehensive testing including bench performance, animal studies, software validation, and leveraged biocompatibility and sterilization data from the predicate demonstrate the subject device performs equivalently and poses no new safety or effectiveness concerns.