Cleared Traditional

K193576 - Solitaire Platinum Revascularization De...

K193576 is the FDA 510(k) clearance for Solitaire Platinum Revascularization De... 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 333-day FDA review.

K193576 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
333d
Days
Class 2
Risk

K193576 is an FDA 510(k) clearance for the Solitaire Platinum Revascularization Device, Solitaire X 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 November 20, 2020 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K193576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date November 20, 2020
Days to Decision 333 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
185d slower than avg
Panel avg: 148d · This submission: 333d
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
NCT02239640 Completed Observational Industry-sponsored

Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry

984
Patients (actual)
55
Sites
Condition studied Ischemic Stroke
Eligibility All sexes
Principal investigator Nils Mueller-Kronast, M.D.
Sponsor Medtronic Neurovascular Clinical Affairs (industry)
Started 2014-08-21 → Primary completion 2016-10-07
Primary outcome
Number of Participants Assessed for Revascularization With mTICI Grades 2b-3
Secondary outcome
Incidence of Neurological Events of Interest
View full study on ClinicalTrials.gov

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

All 16
Devices cleared under the same product code (POL) and FDA review panel - the closest regulatory comparables to K193576.
Trevo NXT ProVue Retriever
K210502 · Stryker Neurovascular · Aug 2021
Solitaire X Revascularization Device
K203358 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Mar 2021
Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
K203219 · Stryker Neurovascular · Dec 2020
Trevo NXT ProVue Retriever
K200117 · Stryker · Feb 2020
Trevo NXT ProVue Retriever
K192207 · Stryker · Nov 2019
Trevo XP ProVue Retriever
K190779 · Stryker · Jun 2019