AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM

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 Aesculap - Meithke Progav 2.0 Adjustable Shunt System.

Pre-market Notification Details

Device IDK141687
510k NumberK141687
Device Name:AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-12
Decision Date2015-04-02
Summary:summary

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