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FDA 510(k)

FLOWRUNNER Aspiration System

K-Number: K254208 · 2026-03-20

ApplicantExpanse Medical, Inc.
Decision Date2026-03-20
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOWRUNNER Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Expanse Medical, Inc.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K254208. 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 FLOWRUNNER Aspiration System?

FLOWRUNNER Aspiration System is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Expanse Medical, Inc.. The 510(k) number is K254208.

When did FLOWRUNNER Aspiration System receive FDA 510(k) clearance?

FLOWRUNNER Aspiration System received FDA 510(k) clearance on 2026-03-20, under 510(k) number K254208.

Who is the listed applicant for FLOWRUNNER Aspiration System?

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

What is the FDA product code for FLOWRUNNER Aspiration System?

The FDA product code for FLOWRUNNER Aspiration System is QEZ.

Other records listing Expanse Medical, Inc. 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.

K251488FLOWRUNNER Aspiration SystemK234073ICE Aspiration System

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.

K261105Powered Aventus Thrombectomy System™Inquis MedicalK262030Aventus Thrombectomy SystemInquis MedicalK253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.K253925Aventus Thrombectomy SystemInquis MedicalK252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, Inc.K251312Vesalio Peripheral SystemVesalio, Inc.

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.

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