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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 a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-12-01 under approval 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. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K173266.

When was Octane aspiration system approved by the FDA?

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

What company makes Octane aspiration system?

Octane aspiration system is manufactured by Vascular Solutions, Inc..

What is the FDA product code for Octane aspiration system?

The FDA product code for Octane aspiration system is QEZ.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Other Devices by Vascular Solutions, Inc.

K161702Endura guidewire K162272Fluent inflation device K161336VSI StraitSet micro-introducer kit K173532Raider Guidewire K170544Langston dual lumen catheter K171946Gel-Bead

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Related Devices (Code: QEZ)

K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC K172000ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K182232Octane Mechanical Thrombectomy SystemVascular Solutions, Inc. K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC K190619Aspiron(TM) Aspiration CatheterMeril Life Sciences Private Limited

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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