Cleared Traditional

K183022 - Solitaire 4 Revascularization Device

K183022 is the FDA 510(k) clearance for Solitaire 4 Revascularization Device by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It is a Class 2 Neurology device (product code POL) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K183022 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
89d
Days
Class 2
Risk

K183022 is an FDA 510(k) clearance for the Solitaire 4 Revascularization Device. Classified as Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (product code POL), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on January 29, 2019 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5600 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Therapeutics, Inc. d/b/a ev3 Neurovascular devices

Submission Details

510(k) Number K183022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2018
Decision Date January 29, 2019
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5600
Definition A Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Is A Prescription Device Used In The Treatment Of Acute Ischemic Stroke To Improve Clinical Outcomes. The Device Is Delivered Into The Neurovasculature With An Endovascular Approach, Mechanically Removes Thrombus From The Body, And Restores Blood Flow In The Neurovasculature.
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 - POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

All 15
Devices cleared under the same product code (POL) and FDA review panel - the closest regulatory comparables to K183022.
Trevo NXT ProVue Retriever
K192207 · Stryker · Nov 2019
Trevo XP ProVue Retriever
K190779 · Stryker · Jun 2019
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)
K181807 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Mar 2019
Solitare Platinum Revascularization Device
K181186 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Oct 2018
Solitaire 2 and Solitaire Platinum Revascularization Device
K181060 · Medtronic Neurovascular · Aug 2018
Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
K173352 · Concentric Medical, Inc. · Feb 2018