Cleared Traditional

SurfRider 13 Microcatheter

K251668 · Kaneka Americas Holding, Inc. · Neurology

Jan 2026

Decision

220d

Days

Class 2

Risk

About This 510(k) Submission

K251668 is an FDA 510(k) clearance for the SurfRider 13 Microcatheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Kaneka Americas Holding, Inc. (Newark, US). The FDA issued a Cleared decision on January 5, 2026, 220 days after receiving the submission on May 30, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K251668 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2025
Decision Date	January 05, 2026
Days to Decision	220 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