Cleared Special

K133464 - MODIFIED TREVO PROVUE RETRIEVER

K133464 is the FDA 510(k) clearance for MODIFIED TREVO PROVUE RETRIEVER by Concentric Medical, Inc.. It is a Class 2 Neurology device (product code NRY) cleared through the Special 510(k) pathway after a 66-day FDA review.

K133464 · Concentric Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
66d
Days
Class 2
Risk

K133464 is an FDA 510(k) clearance for the MODIFIED TREVO PROVUE 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 January 17, 2014 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Concentric Medical, Inc. devices

Submission Details

510(k) Number K133464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2013
Decision Date January 17, 2014
Days to Decision 66 days
Submission Type Special
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
82d faster than avg
Panel avg: 148d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 K133464.
Penumbra System ACE
K142458 · Penumbra, Inc. · May 2015
Trevo XP ProVue Retriever (6X25mm)
K143077 · Concentric Medical, Inc. · Apr 2015
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
K133317 · Penumbra, Inc. · May 2014
MODIFIED TREVO PROVUE RETRIEVER
K132641 · Concentric Medical, Inc. · Jan 2014
MODIFIED TREVO RETRIEVER
K122478 · Concentric Medical, Inc. · Oct 2012
TREVO RETRIEVER
K120961 · Concentric Medical, Inc. · Aug 2012