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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 a medical device manufactured by Volcano Atheromed, Inc.. It received FDA 510(k) clearance on 2020-04-20 under approval 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. It is manufactured by Volcano Atheromed, Inc.. The 510(k) number is K193197.

When was QuickClear Mechanical Thrombectomy System approved by the FDA?

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

What company makes QuickClear Mechanical Thrombectomy System?

QuickClear Mechanical Thrombectomy System is manufactured by Volcano Atheromed, Inc..

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

The FDA product code for QuickClear Mechanical 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 NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_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 NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT07603700 STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Volcano Atheromed, Inc.

K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System K182972Phoenix Atherectomy System K181877Phoenix 2.4mm Atherectomy Plus System K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

Related Devices (Code: QEZ)

K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC 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

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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