Cleared Traditional

SOLITAIRE FR REVASCULARIZATION DEVICE (K113455) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113455 · Micro Therapeutics Dba Ev3 Neurovascular · Neurology device
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Mar 2012
Decision
102d
Days
Class 2
Risk

K113455 is an FDA 510(k) clearance for the SOLITAIRE FR REVASCULARIZATION DEVICE. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Micro Therapeutics Dba Ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on March 2, 2012 after a review of 102 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 Micro Therapeutics Dba Ev3 Neurovascular devices

Submission Details

510(k) Number K113455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date March 02, 2012
Days to Decision 102 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
46d faster than avg
Panel avg: 148d · This submission: 102d
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 107
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