Identifiers
- 510(k) Number
- K250202 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 is a peripheral mechanical thrombectomy device that uses directional aspiration to remove thrombus from the vasculature. It is designed to provide precise, controlled extraction of clot material during endovascular procedures.
The system is cleared in the United States through a 510(k) submission (K250202) as a Class II device and is classified under the cardiovascular advisory committee. It is supplied as a complete platform that includes a dilator, navigation catheter, aspiration component, and integrated blood‑return pathway. The device is intended for single‑use in peripheral vascular interventions and is regulated under the FDA special clearance pathway.
Frequently asked questions
What is the Aventus Thrombectomy System used for?
The Aventus Thrombectomy System is designed to provide precise, controlled extraction of clot material during endovascular procedures by using directional aspiration to remove thrombus from the vasculature in peripheral vascular interventions.
How is the Aventus Thrombectomy System supplied and is it reusable?
The system is supplied as a complete platform that includes a dilator, navigation catheter, aspiration component, and integrated blood-return pathway, and is intended for single-use only in peripheral vascular interventions.
What regulatory pathway was used for the Aventus Thrombectomy System in the United States?
The Aventus Thrombectomy System was cleared in the United States through a 510(k) submission (K250202) as a Class II device under the FDA special clearance pathway and classified under the cardiovascular advisory committee.
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: Inquis Medical | AVENTUS Precision Thrombectomy System, AVENTUS Thrombectomy System for PE | Inquis Medical, PDF AVENTUS Thrombectomy System: Case Presentation, The AVENTUS® Thrombectomy System: Intelligent Design for Precise ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250202 | Class II | Active |
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Manufacturer
- Manufacturer
- Inquis Medical
Sources (1)
- FDA 510(k) K250202 24 fields · synced Sep 27, 2026