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FDA 510(k)

ClearLumen II Peripheral Thrombectomy System

K-Number: K163051 · 2017-02-21

ApplicantWalk Vascular, LLC
Decision Date2017-02-21
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ClearLumen II Peripheral Thrombectomy System is a medical device manufactured by Walk Vascular, LLC. It received FDA 510(k) clearance on 2017-02-21 under approval number K163051. 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 ClearLumen II Peripheral Thrombectomy System?

ClearLumen II Peripheral Thrombectomy System is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Walk Vascular, LLC. The 510(k) number is K163051.

When was ClearLumen II Peripheral Thrombectomy System approved by the FDA?

ClearLumen II Peripheral Thrombectomy System received FDA 510(k) clearance on 2017-02-21, under approval number K163051.

What company makes ClearLumen II Peripheral Thrombectomy System?

ClearLumen II Peripheral Thrombectomy System is manufactured by Walk Vascular, LLC.

What is the FDA product code for ClearLumen II Peripheral Thrombectomy System?

The FDA product code for ClearLumen II Peripheral Thrombectomy System is QEZ.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED

Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Walk Vascular, LLC

K161786ClearLumen II Thrombectomy System K172000ClearLumen II Peripheral Thrombectomy System K192439JETi Peripheral Thrombectomy System K183403JETi 88 Peripheral Thrombectomy System K201998JETi AIO Peripheral Thrombectomy System K213565JETi AIO Peripheral Thrombectomy System

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Related Devices (Code: QEZ)

K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC K173266Octane aspiration systemVascular Solutions, Inc. K172000ClearLumen 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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