FDA applicant

Mivi Neuroscience, Inc.

Eden Prarie, MN5 decisions2015–20232 recalls

FDA records 5 decisions for Mivi Neuroscience, Inc. (Eden Prarie, MN) from 2015 to 2023: 5 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and QJP (Catheter, Percutaneous, Neurovasculature). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 139 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Mivi Neuroscience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2021

2015high 2 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Mivi Neuroscience, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mivi Neuroscience, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Mivi”

FDA records each applicant name separately; these may or may not be the same firm.

Mivi Neurovascular 2 Mivi, LLC 1

Mivi Neuroscience, Inc.

Which product codes does it file in?

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Other applicant names beginning “Mivi”