Cleared Traditional

SOFIA Plus Aspiration Catheter

K173200 · MicroVention, Inc. · Neurology

Jun 2018

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K173200 is an FDA 510(k) clearance for the SOFIA Plus Aspiration Catheter, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on June 11, 2018, 252 days after receiving the submission on October 2, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K173200 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — 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.