Cleared Traditional

ISAAC Neurovascular Navigation Catheter

K222115 · MicroVention, Inc. · Neurology
Jan 2023
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K222115 is an FDA 510(k) clearance for the ISAAC Neurovascular Navigation Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on January 10, 2023, 176 days after receiving the submission on July 18, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K222115 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2022
Decision Date January 10, 2023
Days to Decision 176 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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