Cleared Traditional

K160641 - Solitaire Platinum Revascularization De...

K160641 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 NRY) cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K160641 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
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Mar 2017
Decision
366d
Days
Class 2
Risk

K160641 is an FDA 510(k) clearance for the Solitaire Platinum Revascularization Device, 6x40 mm. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on March 8, 2017 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 K160641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2016
Decision Date March 08, 2017
Days to Decision 366 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 148d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 85
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K160641.
Zenith Flex System
K172167 · Inneuroco, Inc. · Apr 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
K173841 · Stryker · Mar 2018
Penumbra 3D Revascularization Device
K162901 · Penumbra, Inc. · Apr 2017
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