Cleared Special

K123378 - SOLITAIRE 2 REVASCULARIZATION DEVICE

K123378 is an FDA 510(k) clearance for SOLITAIRE 2 REVASCULARIZATION DEVICE, manufactured by Micro Therapeutics Dba Ev3 Neurovascular. The device is a Class 2 Neurology device with product code NRY cleared through the Special 510(k) pathway after a 29-day FDA review.

K123378 · 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
Nov 2012
Decision
29d
Days
Class 2
Risk

K123378 is an FDA 510(k) clearance for the SOLITAIRE 2 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 November 30, 2012 after a review of 29 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.

FDA 510(k) Submission Details - K123378

510(k) Number K123378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2012
Decision Date November 30, 2012
Days to Decision 29 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
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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. 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 114
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K123378.
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K113455 · Micro Therapeutics Dba Ev3 Neurovascular · Mar 2012
K123378 · SOLITAIRE 2 REVASCULARIZATION DEVICE
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