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FDA 510(k)

Powered Aventus Thrombectomy System™

K-Number: K261105 · 2026-07-27

Decision Date2026-07-27
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Powered Aventus Thrombectomy System™ is the device name listed in this FDA 510(k) record. The listed applicant is Inquis Medical. It received FDA 510(k) clearance on 2026-07-27 under 510(k) number K261105. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powered Aventus Thrombectomy System™?

Powered Aventus Thrombectomy System™ is a medical device that received FDA 510(k) clearance on 2026-07-27. The listed applicant is Inquis Medical. The 510(k) number is K261105.

When did Powered Aventus Thrombectomy System™ receive FDA 510(k) clearance?

Powered Aventus Thrombectomy System™ received FDA 510(k) clearance on 2026-07-27, under 510(k) number K261105.

Who is the listed applicant for Powered Aventus Thrombectomy System™?

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 Powered Aventus Thrombectomy System™?

The FDA product code for Powered Aventus Thrombectomy System™ is QEZ.

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.

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Related Devices (Code: QEZ)

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.

Official Source

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