Cleared Traditional

Merlin Aspiration System

K213771 · Mivi Neurovascular, Inc. · Cardiovascular

Jan 2022

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K213771 is an FDA 510(k) clearance for the Merlin Aspiration System, a Catheter, Embolectomy (Class II — Special Controls, product code DXE), submitted by Mivi Neurovascular, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 27, 2022, 56 days after receiving the submission on December 2, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K213771 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2021
Decision Date	January 27, 2022
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF