Cleared Traditional

SOFIA Plus Aspiration Catheter (K173200) - FDA 510(k) Clearance

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

K173200 · MicroVention, Inc. · Neurology device
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Jun 2018
Decision
252d
Days
Class 2
Risk

K173200 is an FDA 510(k) clearance for the SOFIA Plus Aspiration Catheter. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on June 11, 2018 after a review of 252 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 MicroVention, Inc. devices

Submission Details

510(k) Number K173200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date June 11, 2018
Days to Decision 252 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
104d slower than avg
Panel avg: 148d · This submission: 252d
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 72
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K173200.
Penumbra System Reperfusion Catheter JET 7
K173761 · Penumbra, Inc. · Aug 2018
Riptide Aspiration System React 68 Catheter
K180705 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2018
Penumbra System
K180008 · Penumbra, Inc. · Jun 2018
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