Cleared Traditional

K113455 - SOLITAIRE FR REVASCULARIZATION DEVICE

K113455 is an FDA 510(k) clearance for SOLITAIRE FR REVASCULARIZATION DEVICE, manufactured by Micro Therapeutics Dba Ev3 Neurovascular. The device is a Class 2 Neurology device with product code NRY cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K113455 · Micro Therapeutics Dba Ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K113455

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 149d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

NRY Device Classification - Class 2, Special Controls

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
NCT01054560 Completed Interventional Industry-sponsored

SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

144
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Ischemic Stroke
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Jeffrey L. Saver, MD
Sponsor Medtronic Neurovascular Clinical Affairs (industry)
Started 2010-01-01 → Primary completion 2011-07-01
Primary outcome
Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage
Secondary outcome
Time to Initial Recanalization
View full study on ClinicalTrials.gov

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 114
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K113455.
SOLITAIRE 2 REVASCULARIZATION DEVICE
K123378 · Micro Therapeutics Dba Ev3 Neurovascular · Nov 2012
MODIFIED TREVO RETRIEVER
K122478 · Concentric Medical, Inc. · Oct 2012
TREVO RETRIEVER
K120961 · Concentric Medical, Inc. · Aug 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
K113455 · SOLITAIRE FR REVASCULARIZATION DEVICE
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