Cleared Traditional

K182097 - React 71 Catheter

K182097 is the FDA 510(k) clearance for React 71 Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It is a Class 2 Neurology device (product code DQY) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K182097 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
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Nov 2018
Decision
103d
Days
Class 2
Risk

K182097 is an FDA 510(k) clearance for the React 71 Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on November 14, 2018 after a review of 103 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. 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 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular devices

Submission Details

510(k) Number K182097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2018
Decision Date November 14, 2018
Days to Decision 103 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
45d faster than avg
Panel avg: 148d · This submission: 103d
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 K182097.
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