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FDA 510(k)

ClearLumen II Thrombectomy System

K-Number: K161786 · 2016-10-18

ApplicantWalk Vascular, LLC
Decision Date2016-10-18
Product CodeQEZ
Advisory CommitteeCV
DecisionUnknown

Device Summary

ClearLumen II 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 2016-10-18 under 510(k) number K161786. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ClearLumen II Thrombectomy System?

ClearLumen II Thrombectomy System is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Walk Vascular, LLC. The 510(k) number is K161786.

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

ClearLumen II Thrombectomy System received FDA 510(k) clearance on 2016-10-18, under 510(k) number K161786.

Who is the listed applicant for ClearLumen II 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 Thrombectomy System?

The FDA product code for ClearLumen II 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 SystemK163051ClearLumen II Peripheral 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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