ENDOSCOPIC VENTRICULAR CATHETER

Shunt, Central Nervous System And Components

INTEGRA NEUROCARE LLC.

The following data is part of a premarket notification filed by Integra Neurocare Llc. with the FDA for Endoscopic Ventricular Catheter.

Pre-market Notification Details

Device IDK971617
510k NumberK971617
Device Name:ENDOSCOPIC VENTRICULAR CATHETER
ClassificationShunt, Central Nervous System And Components
Applicant INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie,  WI  53150 -0390
ContactLori L Hays
CorrespondentLori L Hays
INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie,  WI  53150 -0390
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-02
Decision Date1997-07-31

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