Not Cleared Direct

DEN150049 - 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 is an FDA 510(k) submission for Modified Trevo ProVue Retriever, manufactured by Concentric Medical, Inc.. The device is a Class 2 Neurology device with product code POL cleared through the Direct 510(k) pathway after a 312-day FDA review.

DEN150049 · Concentric Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
312d
Days
Class 2
Risk

DEN150049 is an FDA 510(k) submission (not cleared) for the Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP P.... Classified as Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (product code POL), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on September 2, 2016 after a review of 312 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 312 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Concentric Medical, Inc. devices

FDA 510(k) Submission Details - DEN150049

510(k) Number DEN150049 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 26, 2015
Decision Date September 02, 2016
Days to Decision 312 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 148d · This submission: 312d
Pathway characteristics

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. 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 17
Devices cleared under the same product code (POL) and FDA review panel - the closest regulatory comparables to DEN150049.
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
Solitaire 2 Revascularization Device
K162539 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Nov 2016