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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 the device name listed in this FDA 510(k) record. The listed applicant is Walk Vascular, LLC. It received FDA 510(k) clearance on 2017-02-21 under 510(k) 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. The listed applicant is Walk Vascular, LLC. The 510(k) number is K163051.

When did ClearLumen II Peripheral Thrombectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for ClearLumen II 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 ClearLumen II Peripheral Thrombectomy System?

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

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.

K213565JETi AIO Peripheral Thrombectomy SystemK201998JETi AIO Peripheral Thrombectomy SystemK192439JETi Peripheral Thrombectomy SystemK183403JETi 88 Peripheral Thrombectomy SystemK172000ClearLumen 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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