Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Other records listing Mivi Neurovascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192558Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter

Related Devices (Code: DXE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLCK241330Fogarty Fortis Arterial Embolectomy CatheterEdwards LifesciencesK233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards LifesciencesK233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLCK233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards LifesciencesK202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterApplied Medical Resources Corporation

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.

↑