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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 a medical device manufactured by Walk Vascular, LLC. It received FDA 510(k) clearance on 2016-10-18 under approval 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. It is manufactured by Walk Vascular, LLC. The 510(k) number is K161786.

When was ClearLumen II Thrombectomy System approved by the FDA?

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

What company makes ClearLumen II Thrombectomy System?

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

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

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

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING 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 NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING NCT07135895 The ArtixASCEND Study RECRUITING

Other Devices by Walk Vascular, LLC

K172000ClearLumen II Peripheral Thrombectomy System K163051ClearLumen II Peripheral Thrombectomy System K192439JETi Peripheral Thrombectomy System K183403JETi 88 Peripheral Thrombectomy System K201998JETi AIO Peripheral Thrombectomy System K213565JETi AIO Peripheral Thrombectomy System

View all 7 devices →

Related Devices (Code: QEZ)

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 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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