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FDA 510(k)

QuickClear Mechanical Thrombectomy System

K-Number: K193197 · 2020-04-20

ApplicantVolcano Atheromed, Inc.
Decision Date2020-04-20
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QuickClear Mechanical Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Atheromed, Inc.. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K193197. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuickClear Mechanical Thrombectomy System?

QuickClear Mechanical Thrombectomy System is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Volcano Atheromed, Inc.. The 510(k) number is K193197.

When did QuickClear Mechanical Thrombectomy System receive FDA 510(k) clearance?

QuickClear Mechanical Thrombectomy System received FDA 510(k) clearance on 2020-04-20, under 510(k) number K193197.

Who is the listed applicant for QuickClear Mechanical Thrombectomy System?

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

What is the FDA product code for QuickClear Mechanical Thrombectomy System?

The FDA product code for QuickClear Mechanical Thrombectomy System is QEZ.

Other records listing Volcano Atheromed, 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.

K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy SystemK182972Phoenix Atherectomy SystemK181877Phoenix 2.4mm Atherectomy Plus SystemK1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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