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FDA 510(k)

NeVa PV Thrombectomy Device

K-Number: K253407 · 2025-11-24

ApplicantVesalio, Inc.
Decision Date2025-11-24
Product CodeQEX
Advisory CommitteeCV
DecisionUnknown

Device Summary

NeVa PV Thrombectomy Device is a medical device manufactured by Vesalio, Inc.. It received FDA 510(k) clearance on 2025-11-24 under approval number K253407. The device is classified under product code QEX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

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 2025-11-24. It is manufactured by Vesalio, Inc.. The 510(k) number is K253407.

When was NeVa PV Thrombectomy Device approved by the FDA?

NeVa PV Thrombectomy Device received FDA 510(k) clearance on 2025-11-24, under approval number K253407.

What company makes NeVa PV Thrombectomy Device?

NeVa PV Thrombectomy Device is manufactured by Vesalio, Inc..

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

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

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

Other Devices by Vesalio, Inc.

K251006NeVasc Aspiration System K251312Vesalio Peripheral System K251097V-DAC Catheter

Related Devices (Code: QEX)

K171493MegaVac Mechanical Thrombectomy SystemCapture Vascular, Inc. K163618INDIGO Aspiration SystemPenumbra, 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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