Cleared Traditional

Scepter Mini Occlusion Balloon Catheter

K182829 · MicroVention, Inc. · Neurology
Jul 2019
Decision
278d
Days
Class 2
Risk

About This 510(k) Submission

K182829 is an FDA 510(k) clearance for the Scepter Mini Occlusion Balloon 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 July 10, 2019, 278 days after receiving the submission on October 5, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K182829 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2018
Decision Date July 10, 2019
Days to Decision 278 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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