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FDA 510(k)

JETi AIO Peripheral Thrombectomy System

K-Number: K213565 · 2022-02-01

ApplicantWalk Vascular, LLC
Decision Date2022-02-01
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JETi AIO Peripheral Thrombectomy System is a medical device manufactured by Walk Vascular, LLC. It received FDA 510(k) clearance on 2022-02-01 under approval number K213565. 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 JETi AIO Peripheral Thrombectomy System?

JETi AIO Peripheral Thrombectomy System is a medical device that received FDA 510(k) clearance on 2022-02-01. It is manufactured by Walk Vascular, LLC. The 510(k) number is K213565.

When was JETi AIO Peripheral Thrombectomy System approved by the FDA?

JETi AIO Peripheral Thrombectomy System received FDA 510(k) clearance on 2022-02-01, under approval number K213565.

What company makes JETi AIO Peripheral Thrombectomy System?

JETi AIO Peripheral Thrombectomy System is manufactured by Walk Vascular, LLC.

What is the FDA product code for JETi AIO Peripheral Thrombectomy System?

The FDA product code for JETi AIO 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 K163051ClearLumen II Peripheral Thrombectomy System K192439JETi Peripheral Thrombectomy System K183403JETi 88 Peripheral Thrombectomy System K201998JETi 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 K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K182232Octane Mechanical Thrombectomy SystemVascular Solutions, Inc. K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC

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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