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FDA 510(k)

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator

K-Number: K200871 · 2020-05-04

ApplicantControl Medical Technology
Decision Date2020-05-04
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator is a medical device manufactured by Control Medical Technology. It received FDA 510(k) clearance on 2020-05-04 under approval number K200871. 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 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator?

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator is a medical device that received FDA 510(k) clearance on 2020-05-04. It is manufactured by Control Medical Technology. The 510(k) number is K200871.

When was Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator approved by the FDA?

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator received FDA 510(k) clearance on 2020-05-04, under approval number K200871.

What company makes Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator?

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator is manufactured by Control Medical Technology.

What is the FDA product code for Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator?

The FDA product code for Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator 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 Control Medical Technology

K200629Aspire Mechanical Aspirator G

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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