Cleared Traditional

K162539 - Solitaire 2 Revascularization Device

K162539 is an FDA 510(k) clearance for Solitaire 2 Revascularization Device, manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device is a Class 2 Neurology device with product code POL cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K162539 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
59d
Days
Class 2
Risk

K162539 is an FDA 510(k) clearance for the Solitaire 2 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 November 10, 2016 after a review of 59 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

FDA 510(k) Submission Details - K162539

510(k) Number K162539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2016
Decision Date November 10, 2016
Days to Decision 59 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
89d faster than avg
Panel avg: 148d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

POL Device Classification - Class 2, Special Controls

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
NCT01657461 Completed Interventional Industry-sponsored

Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial

Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial

196
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Acute Ischemic Stroke
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Jeffrey Saver, MD
Sponsor Medtronic Neurovascular Clinical Affairs (industry)
Started 2012-12-01 → Primary completion 2015-01-01
Primary outcome
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
Secondary outcome
Death Due to Any Cause at 90 Days
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 K162539.
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
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
DEN150049 · Concentric Medical, Inc. · Sep 2016