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FDA 510(k)

Vesalio Peripheral System

K-Number: K251312 · 2025-10-24

ApplicantVesalio, Inc.
Decision Date2025-10-24
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vesalio Peripheral System is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio, Inc.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K251312. 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 Vesalio Peripheral System?

Vesalio Peripheral System is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Vesalio, Inc.. The 510(k) number is K251312.

When did Vesalio Peripheral System receive FDA 510(k) clearance?

Vesalio Peripheral System received FDA 510(k) clearance on 2025-10-24, under 510(k) number K251312.

Who is the listed applicant for Vesalio Peripheral System?

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

What is the FDA product code for Vesalio Peripheral System?

The FDA product code for Vesalio Peripheral System is QEZ.

Related Clinical Trials

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Other records listing Vesalio, Inc. as applicant

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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.

K261105Powered Aventus Thrombectomy System™Inquis MedicalK262030Aventus Thrombectomy SystemInquis MedicalK253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.K253925Aventus Thrombectomy SystemInquis MedicalK252509AlphaVac Multipurpose Mechanical Aspiration System F1885AngioDynamics, 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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