Ventricular Catheter

FDA 510(k) K200950 · Aesculap, Inc.

Substantially Equivalent

510(k) numberK200950

Submission

Device name
Ventricular Catheter
Applicant
Aesculap, Inc.
Center Valley, PA, US
Received
April 9, 2020
Decision date
May 8, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

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Questions and answers

When was Ventricular Catheter cleared by the FDA?

Ventricular Catheter (K200950) received a 510(k) decision of Substantially Equivalent on May 8, 2020, 29 days after the submission was received.

What is the product code of K200950?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.