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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 the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2022-02-24 under 510(k) 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. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K211798.

When did Cleaner Plus Thrombectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for Cleaner Plus Thrombectomy System?

The FDA 510(k) record lists Argon Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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NCT07102160Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended TrackingRECRUITING

Other records listing Argon Medical Devices, Inc. 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.

K252795ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with CoaxialK260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterK251318VariFuse Adjustable Infusion CatheterK253741V•Stick™ Vascular Access SetK242612Option ELITE Vena Cava Filter System (352506070E 352506100E)K241145TLAB® Transvenous Liver Biopsy System (TF-18C)

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Related Devices (Code: QEW)

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.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

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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