Cleared Traditional

Broadway 8 Catheter

K241768 · Stryker Neurovascular · Neurology

Dec 2024

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K241768 is an FDA 510(k) clearance for the Broadway 8 Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on December 19, 2024, 182 days after receiving the submission on June 20, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K241768 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2024
Decision Date	December 19, 2024
Days to Decision	182 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