Dir 800

FDA 510(k) K202391 · Aesculap, Inc.

Substantially Equivalent

510(k) numberK202391

Submission

Device name
Dir 800
Applicant
Aesculap, Inc.
Center Valley, PA, US
Received
August 21, 2020
Decision date
January 21, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZI – System, X-Ray, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1600
Specialty
Radiology

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Questions and answers

When was Dir 800 cleared by the FDA?

Dir 800 (K202391) received a 510(k) decision of Substantially Equivalent on January 21, 2021, 153 days after the submission was received.

What is the product code of K202391?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.