Cleared Traditional

K192558 - Q3 Distal Access Catheter

K192558 is the FDA 510(k) clearance for Q3 Distal Access Catheter by Mivi Neurovascular. It is a Class 2 Neurology device (product code DQY) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K192558 · Mivi Neurovascular · Neurology device
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Apr 2020
Decision
202d
Days
Class 2
Risk

K192558 is an FDA 510(k) clearance for the Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Cathet.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Mivi Neurovascular (Eden Prarie, US). The FDA issued a Cleared decision on April 6, 2020 after a review of 202 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mivi Neurovascular devices

Submission Details

510(k) Number K192558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2019
Decision Date April 06, 2020
Days to Decision 202 days
Submission Type Traditional
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
54d slower than avg
Panel avg: 148d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K192558.
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Wingman 14, Wingman 14C, Wingman 18, Wingman 35
K193596 · Reflow Medical · Feb 2020