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FDA 510(k)

NeVa PV Thrombectomy Device

K-Number: K201085 · 2021-01-15

ApplicantVesalio
Decision Date2021-01-15
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NeVa PV Thrombectomy Device is a medical device manufactured by Vesalio. It received FDA 510(k) clearance on 2021-01-15 under approval number K201085. 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 NeVa PV Thrombectomy Device?

NeVa PV Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2021-01-15. It is manufactured by Vesalio. The 510(k) number is K201085.

When was NeVa PV Thrombectomy Device approved by the FDA?

NeVa PV Thrombectomy Device received FDA 510(k) clearance on 2021-01-15, under approval number K201085.

What company makes NeVa PV Thrombectomy Device?

NeVa PV Thrombectomy Device is manufactured by Vesalio.

What is the FDA product code for NeVa PV Thrombectomy Device?

The FDA product code for NeVa PV Thrombectomy Device is QEW.

Related Clinical Trials

NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT07566598 Measuring Absolute Brain Flow and Brain Microcirculation Resistance by Continuous Thermodilution RECRUITING NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING NCT03359434 Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke COMPLETED NCT06733246 Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients RECRUITING

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

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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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