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FDA 510(k)

Octane Mechanical Thrombectomy System

K-Number: K182232 · 2018-09-11

ApplicantVascular Solutions, Inc.
Decision Date2018-09-11
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Octane Mechanical Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K182232. 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 Octane Mechanical Thrombectomy System?

Octane Mechanical Thrombectomy System is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K182232.

When did Octane Mechanical Thrombectomy System receive FDA 510(k) clearance?

Octane Mechanical Thrombectomy System received FDA 510(k) clearance on 2018-09-11, under 510(k) number K182232.

Who is the listed applicant for Octane Mechanical Thrombectomy System?

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

What is the FDA product code for Octane Mechanical Thrombectomy System?

The FDA product code for Octane Mechanical Thrombectomy System is QEZ.

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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

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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