Cleared Special

Rist 071 Radial Access Guide Catheter

K211990 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology
Jul 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K211990 is an FDA 510(k) clearance for the Rist 071 Radial Access Guide Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Lrvine, US). The FDA issued a Cleared decision on July 27, 2021, 29 days after receiving the submission on June 28, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K211990 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2021
Decision Date July 27, 2021
Days to Decision 29 days
Submission Type Special
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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