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FDA 510(k)

Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister

K-Number: K232679 · 2024-01-19

ApplicantArgon Medical Devices, Inc.
Decision Date2024-01-19
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister 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 2024-01-19 under 510(k) number K232679. 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™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister?

Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K232679.

When did Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister receive FDA 510(k) clearance?

Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister received FDA 510(k) clearance on 2024-01-19, under 510(k) number K232679.

Who is the listed applicant for Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister?

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™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister?

The FDA product code for Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister is QEW.

Related Clinical Trials

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.

NCT07102160Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended TrackingRECRUITINGNCT06189313CLEANer Aspiration for Pulmonary EmbolismSUSPENDEDNCT07571954Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for ThrombectomyNOT_YET_RECRUITING

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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