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FDA 510(k)

Aventus Thrombectomy System (IM-2100)

K-Number: K250668 · 2025-03-25

ApplicantInquis Medical
Decision Date2025-03-25
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aventus Thrombectomy System (IM-2100) is the device name listed in this FDA 510(k) record. The listed applicant is Inquis Medical. It received FDA 510(k) clearance on 2025-03-25 under 510(k) number K250668. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aventus Thrombectomy System (IM-2100)?

Aventus Thrombectomy System (IM-2100) is a medical device that received FDA 510(k) clearance on 2025-03-25. The listed applicant is Inquis Medical. The 510(k) number is K250668.

When did Aventus Thrombectomy System (IM-2100) receive FDA 510(k) clearance?

Aventus Thrombectomy System (IM-2100) received FDA 510(k) clearance on 2025-03-25, under 510(k) number K250668.

Who is the listed applicant for Aventus Thrombectomy System (IM-2100)?

The FDA 510(k) record lists Inquis Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aventus Thrombectomy System (IM-2100)?

The FDA product code for Aventus Thrombectomy System (IM-2100) is QEW.

Other records listing Inquis Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261105Powered Aventus Thrombectomy System™K262030Aventus Thrombectomy SystemK260091Aventus Introducer SheathK253925Aventus Thrombectomy SystemK251189Aventus Thrombectomy SystemK250202Aventus Thrombectomy System

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Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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