Aventus Thrombectomy System (IM-2001/IM-0002)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240117 FDA 510(k)
- FDA Product Code
- QEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aventus Thrombectomy System (IM-2001/IM-0002) is a Peripheral Mechanical Thrombectomy With Aspiration device, designed for the manual aspiration of emboli or thrombi within peripheral blood vessels. It employs a catheter-based approach to facilitate minimally invasive removal of clots, aiding in the restoration of blood flow in affected arteries.
The system comprises an aspiration catheter, a 60-cc dual-action syringe, and a clot canister, supplied as a reusable or single-use kit depending on the configuration. It is classified as a Class II medical device under FDA regulations (870.5150) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Usage is restricted to clinical settings with appropriate vascular access and thrombectomy protocols.
Frequently asked questions
What types of clots can the Aventus Thrombectomy System remove, and how does it work?
The Aventus Thrombectomy System is designed specifically for the manual aspiration of emboli or thrombi within peripheral blood vessels. It uses a catheter-based approach to mechanically remove clots from arteries, helping to restore blood flow in affected areas. The system combines an aspiration catheter with a 60-cc dual-action syringe and a clot canister to manually suction and collect clots during the procedure.
Is the Aventus Thrombectomy System reusable or single-use, and what components are included in each configuration?
The Aventus Thrombectomy System is available in both reusable and single-use configurations. The kit includes an aspiration catheter, a 60-cc dual-action syringe, and a clot canister. The choice between reusable and single-use depends on the specific clinical setup and protocol, though the reusable components are designed for repeated use in controlled environments.
What is the regulatory pathway for the Aventus Thrombectomy System, and what does this mean for clinicians?
The Aventus Thrombectomy System has received FDA 510(k) clearance, meaning it has been determined to be substantially equivalent to predicate devices already on the market. This clearance is specific to peripheral mechanical thrombectomy with aspiration and confirms its compliance with FDA regulations under device classification 870.5150. Clinicians can rely on this approval as evidence of the system’s safety and effectiveness for its intended use.
How should the Aventus Thrombectomy System be stored, and are there any special handling requirements?
While the device data does not specify storage conditions explicitly, the system’s components—such as the aspiration catheter, syringe, and clot canister—should be stored according to standard medical device protocols. This typically includes protection from contamination, extreme temperatures, and physical damage. If the system is single-use, it should be stored in a sterile or clean environment until use, while reusable components should follow manufacturer guidelines for cleaning and sterilization.
What medical specialties or clinical settings is the Aventus Thrombectomy System intended for?
The Aventus Thrombectomy System is classified under the medical specialty of *Cardiovascular* and is intended for use in clinical settings with appropriate vascular access and thrombectomy protocols. It is designed for interventional cardiologists, vascular surgeons, or other specialists trained in peripheral vascular procedures to remove clots from peripheral arteries.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aventus Thrombectomy System (IM-2001/IM-0002) (K240117) — FDA 510 (k ..., Inquis Medical | AVENTUS Precision Thrombectomy System, AVENTUS Thrombectomy System: Innovative Endovascular Solution for ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240117 | Class II | Active |
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Manufacturer
- Manufacturer
- Inquis Medical
Sources (1)
- FDA 510(k) K240117 24 fields · synced Sep 19, 2026