Cleared Special

K212402 - MIVI Q Distal Access Catheter (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K212402 · Mivi Neuroscience, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
136d
Days
Class 2
Risk

K212402 is an FDA 510(k) clearance for the MIVI Q Distal Access Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Mivi Neuroscience, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 16, 2021 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mivi Neuroscience, Inc. devices

Submission Details

510(k) Number K212402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2021
Decision Date December 16, 2021
Days to Decision 136 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 148d · This submission: 136d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 88
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K212402.
BosCATH Support Catheter
K254046 · Sonorous NV, Inc. · Apr 2026
Next Generation 088 Catheter
K254223 · Balt USA, LLC · Apr 2026
PATH BGC
K260938 · Crossroads Neurovascular, Inc. · Apr 2026
Radical 6F Access Catheter
K253975 · Maduro Medical, Inc. · Apr 2026
AXS Lift Intracranial Base Catheter
K253032 · Stryker Neurovascular · Feb 2026
Toro 88 Superbore Catheter
K252297 · Toro Neurovascular, Inc. · Jan 2026