Cleared Traditional

Penumbra 3D Revascularization Device (K162901) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K162901 · Penumbra, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
185d
Days
Class 2
Risk

K162901 is an FDA 510(k) clearance for the Penumbra 3D Revascularization Device. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on April 20, 2017 after a review of 185 days - an extended review cycle.

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 Penumbra, Inc. devices

Submission Details

510(k) Number K162901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date April 20, 2017
Days to Decision 185 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
37d slower than avg
Panel avg: 148d · This submission: 185d
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
NCT01584609 Completed Interventional Industry-sponsored

A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

198
Patients (actual)
8
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Acute Ischemic Stroke From Large Vessel Occlusion
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Don Frei, MD
Sponsor Penumbra Inc. (industry)
Started 2012-04-01 → Primary completion 2017-06-01 → Completed 2017-12-01
Primary outcome
Number of Participants With Angiographic Revascularization of the Occluded Target Vessel
Secondary outcome
Good Clinical Outcome at 30 Days
View full study on ClinicalTrials.gov

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 84
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K162901.
EmboTrap ll Revascularization Device
K173452 · Neuravi, Ltd. · May 2018
Zenith Flex System
K172167 · Inneuroco, Inc. · Apr 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
K173841 · Stryker · Mar 2018
Penumbra System ACE 68 Reperfusion Catheter
K161640 · Penumbra, Inc. · Jul 2016
Penumbra System ACE 68 Reperfusion Catheter
K161064 · Penumbra, Inc. · Jun 2016
Penumbra System, Penumbra Pump MAX
K160449 · Penumbra, Inc. · May 2016