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FDA 510(k)

ROVO Mechanical Thrombectomy Device

K-Number: K220780 · 2023-03-31

Applicant2mg, Inc.
Decision Date2023-03-31
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROVO Mechanical Thrombectomy Device is a medical device manufactured by 2mg, Inc.. It received FDA 510(k) clearance on 2023-03-31 under approval number K220780. 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 ROVO Mechanical Thrombectomy Device?

ROVO Mechanical Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2023-03-31. It is manufactured by 2mg, Inc.. The 510(k) number is K220780.

When was ROVO Mechanical Thrombectomy Device approved by the FDA?

ROVO Mechanical Thrombectomy Device received FDA 510(k) clearance on 2023-03-31, under approval number K220780.

What company makes ROVO Mechanical Thrombectomy Device?

ROVO Mechanical Thrombectomy Device is manufactured by 2mg, Inc..

What is the FDA product code for ROVO Mechanical Thrombectomy Device?

The FDA product code for ROVO Mechanical Thrombectomy Device is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) 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)

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, Inc.

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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