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FDA 510(k)

AXS Vecta Aspiration System

K-Number: K190212 · 2019-04-24

ApplicantStryker Neurovascular
Decision Date2019-04-24
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AXS Vecta Aspiration System is a medical device manufactured by Stryker Neurovascular. It received FDA 510(k) clearance on 2019-04-24 under approval number K190212. 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 AXS Vecta Aspiration System?

AXS Vecta Aspiration System is a medical device that received FDA 510(k) clearance on 2019-04-24. It is manufactured by Stryker Neurovascular. The 510(k) number is K190212.

When was AXS Vecta Aspiration System approved by the FDA?

AXS Vecta Aspiration System received FDA 510(k) clearance on 2019-04-24, under approval number K190212.

What company makes AXS Vecta Aspiration System?

AXS Vecta Aspiration System is manufactured by Stryker Neurovascular.

What is the FDA product code for AXS Vecta Aspiration System?

The FDA product code for AXS Vecta 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 Stryker Neurovascular

K161429Target Detachable Coils K153658Target Detachable Coils K160096InZone Detachment System K163259AXS Offset Delivery Assist Catheter K190833AXS Vecta Aspiration Catheter K193034AXS Infinity LS Plus Long Sheath

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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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