Cleared Traditional

K120961 - TREVO RETRIEVER

K120961 is the FDA 510(k) clearance for TREVO RETRIEVER by Concentric Medical, Inc.. It is a Class 2 Neurology device (product code NRY) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K120961 · Concentric Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
126d
Days
Class 2
Risk

K120961 is an FDA 510(k) clearance for the TREVO RETRIEVER. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Concentric Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 3, 2012 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - 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 Concentric Medical, Inc. devices

Submission Details

510(k) Number K120961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2012
Decision Date August 03, 2012
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
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
NCT01270867 Completed Interventional Industry-sponsored

Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke

Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO 2)

178
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Ischemic Stroke
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Raul G Nogueira, MD
Sponsor Stryker Neurovascular (industry)
Started 2011-02-01 → Primary completion 2011-12-01 → Completed 2012-03-01
Primary outcome
Primary Efficacy Endpoint
Secondary outcome
Secondary Endpoint
View full study on ClinicalTrials.gov

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 100
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K120961.
MODIFIED TREVO PROVUE RETRIEVER
K133464 · Concentric Medical, Inc. · Jan 2014
MODIFIED TREVO PROVUE RETRIEVER
K132641 · Concentric Medical, Inc. · Jan 2014
MODIFIED TREVO RETRIEVER
K122478 · Concentric Medical, Inc. · Oct 2012
PENUMBRA SYSTEM MAX
K113163 · Penumbra, Inc. · Nov 2011
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
K093610 · Concentric Medical, Inc. · Feb 2011
PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
K100769 · Penumbra, Inc. · May 2010