FDA 510(k)

Merlin Aspiration System

Número K: K213771 · 2022-01-27

Data da decisão2022-01-27

Código do produtoDXE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the Merlin Aspiration System?

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

When did Merlin Aspiration System receive FDA 510(k) clearance?

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

Who is the listed applicant for Merlin Aspiration System?

The FDA 510(k) record lists Mivi Neurovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merlin Aspiration System?

The FDA product code for Merlin Aspiration System is DXE.

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