Cleared Traditional

Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) (K181807) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K181807 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
243d
Days
Class 2
Risk

K181807 is an FDA 510(k) clearance for the Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization De.... 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 March 6, 2019 after a review of 243 days - an extended review 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: 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 K181807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2018
Decision Date March 06, 2019
Days to Decision 243 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
95d slower than avg
Panel avg: 148d · This submission: 243d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02586415 Terminated Interventional

Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3

182
Patients (actual)
40
Sites
Treatment
Purpose
Open label
Masking
Condition studied Stroke, Acute; Cerebral Infarction
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Gregory Albers, MD
Sponsor Gregory W Albers
Started 2016-04-01 → Primary completion 2017-08-23
Primary outcome
The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90
Secondary outcome
Count of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence
View full study on ClinicalTrials.gov

Regulatory Peers - POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

All 17
Devices cleared under the same product code (POL) and FDA review panel - the closest regulatory comparables to K181807.
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
K242676 · Phenox Limited · Feb 2025
pRESET LITE Thrombectomy Device
K231539 · Phenox Limited · Oct 2023
Trevo NXT ProVue Retriever
K223305 · Stryker Neurovascular · Mar 2023
pRESET Thrombectomy Device
K222848 · Phenox Limited · Jan 2023
Trevo NXT ProVue Retriever
K210502 · Stryker Neurovascular · Aug 2021
Solitaire X Revascularization Device
K203358 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Mar 2021