Cleared Special

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter

K241388 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology

Jan 2025

Decision

232d

Days

Class 2

Risk

About This 510(k) Submission

K241388 is an FDA 510(k) clearance for the Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Lrvine, US). The FDA issued a Cleared decision on January 2, 2025, 232 days after receiving the submission on May 15, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K241388 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2024
Decision Date	January 02, 2025
Days to Decision	232 days
Submission Type	Special
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