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FDA 510(k)

NeVasc Aspiration System

K-Number: K251006 · 2025-11-10

ApplicantVesalio, Inc.
Decision Date2025-11-10
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NeVasc Aspiration System is a medical device manufactured by Vesalio, Inc.. It received FDA 510(k) clearance on 2025-11-10 under approval number K251006. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeVasc Aspiration System?

NeVasc Aspiration System is a medical device that received FDA 510(k) clearance on 2025-11-10. It is manufactured by Vesalio, Inc.. The 510(k) number is K251006.

When was NeVasc Aspiration System approved by the FDA?

NeVasc Aspiration System received FDA 510(k) clearance on 2025-11-10, under approval number K251006.

What company makes NeVasc Aspiration System?

NeVasc Aspiration System is manufactured by Vesalio, Inc..

What is the FDA product code for NeVasc Aspiration System?

The FDA product code for NeVasc Aspiration System is NRY.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Other Devices by Vesalio, Inc.

K253407NeVa PV Thrombectomy Device K251312Vesalio Peripheral System K251097V-DAC Catheter

Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

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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