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FDA 510(k)

Merlin Aspiration System

K-Number: K213771 · 2022-01-27

ApplicantMivi Neurovascular, Inc.
Decision Date2022-01-27
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Merlin Aspiration System is a medical device manufactured by Mivi Neurovascular, Inc.. It received FDA 510(k) clearance on 2022-01-27 under approval number K213771. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Merlin Aspiration System?

Merlin Aspiration System is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Mivi Neurovascular, Inc.. The 510(k) number is K213771.

When was Merlin Aspiration System approved by the FDA?

Merlin Aspiration System received FDA 510(k) clearance on 2022-01-27, under approval number K213771.

What company makes Merlin Aspiration System?

Merlin Aspiration System is manufactured by Mivi Neurovascular, Inc..

What is the FDA product code for Merlin Aspiration System?

The FDA product code for Merlin Aspiration System is DXE.

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

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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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