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FDA 510(k)

Cleaner Plus Thrombectomy System

K-Number: K211798 · 2022-02-24

ApplicantArgon Medical Devices, Inc.
Decision Date2022-02-24
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cleaner Plus Thrombectomy System is a medical device manufactured by Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2022-02-24 under approval number K211798. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cleaner Plus Thrombectomy System?

Cleaner Plus Thrombectomy System is a medical device that received FDA 510(k) clearance on 2022-02-24. It is manufactured by Argon Medical Devices, Inc.. The 510(k) number is K211798.

When was Cleaner Plus Thrombectomy System approved by the FDA?

Cleaner Plus Thrombectomy System received FDA 510(k) clearance on 2022-02-24, under approval number K211798.

What company makes Cleaner Plus Thrombectomy System?

Cleaner Plus Thrombectomy System is manufactured by Argon Medical Devices, Inc..

What is the FDA product code for Cleaner Plus Thrombectomy System?

The FDA product code for Cleaner Plus Thrombectomy System is QEW.

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 Argon Medical Devices, Inc.

K160785Worker Guidewire K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set K200268Halo™ Single-Loop Snare Kit K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set K200963Halo Single-Loop Microsnare Kit

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Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, 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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