Cleared Traditional

DIR 800

K202391 · Aesculap, Inc. · Neurology
Jan 2021
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K202391 is an FDA 510(k) clearance for the DIR 800, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on January 21, 2021, 153 days after receiving the submission on August 21, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K202391 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2020
Decision Date January 21, 2021
Days to Decision 153 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code IZI — System, X-ray, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1600

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