Ventricular Catheter

Shunt, Central Nervous System And Components

Aesculap, Inc.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Ventricular Catheter.

Pre-market Notification Details

Device IDK200950
510k NumberK200950
Device Name:Ventricular Catheter
ClassificationShunt, Central Nervous System And Components
Applicant Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
ContactKathy A. Racosky
CorrespondentKathy A. Racosky
Aesculap, Inc. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-09
Decision Date2020-05-08

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