Cleared Traditional

SOFIA EX Intracranial Support Catheter

K182602 · MicroVention, Inc. · Neurology
May 2019
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K182602 is an FDA 510(k) clearance for the SOFIA EX Intracranial Support Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by MicroVention, Inc. (Aliso Veijo, US). The FDA issued a Cleared decision on May 15, 2019, 236 days after receiving the submission on September 21, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K182602 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2018
Decision Date May 15, 2019
Days to Decision 236 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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