Cleared Traditional

Toro 88 Superbore Catheter

K252297 · Toro Neurovascular, Inc. · Neurology
Jan 2026
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K252297 is an FDA 510(k) clearance for the Toro 88 Superbore Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Toro Neurovascular, Inc. (Irvine, US). The FDA issued a Cleared decision on January 16, 2026, 177 days after receiving the submission on July 23, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K252297 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2025
Decision Date January 16, 2026
Days to Decision 177 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QJP — Catheter, Percutaneous, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures