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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 the device name listed in this FDA 510(k) record. The listed applicant is Walk Vascular, LLC. It received FDA 510(k) clearance on 2022-02-01 under 510(k) 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. The listed applicant is Walk Vascular, LLC. The 510(k) number is K213565.

When did JETi AIO Peripheral Thrombectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for JETi AIO Peripheral Thrombectomy System?

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

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

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.

NCT07027878JETi Lower Extremity Venous ThrombosisCOMPLETED

Other records listing Walk Vascular, LLC as applicant

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.

K201998JETi AIO Peripheral Thrombectomy SystemK192439JETi Peripheral Thrombectomy SystemK183403JETi 88 Peripheral Thrombectomy SystemK172000ClearLumen II Peripheral Thrombectomy SystemK163051ClearLumen II Peripheral Thrombectomy SystemK161786ClearLumen II Thrombectomy System

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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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