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FDA 510(k)

Octane aspiration system

K-Number: K173266 · 2017-12-01

ApplicantVascular Solutions, Inc.
Decision Date2017-12-01
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Octane aspiration 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 2017-12-01 under 510(k) number K173266. 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 aspiration system?

Octane aspiration system is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K173266.

When did Octane aspiration system receive FDA 510(k) clearance?

Octane aspiration system received FDA 510(k) clearance on 2017-12-01, under 510(k) number K173266.

Who is the listed applicant for Octane aspiration 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 aspiration system?

The FDA product code for Octane aspiration 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.

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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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