CODMAN MICROSENSOR VENTRICULAR CATHETER KIT

Device, Monitoring, Intracranial Pressure

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman Microsensor Ventricular Catheter Kit.

Pre-market Notification Details

Device IDK991222
510k NumberK991222
Device Name:CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactJames M Flaherty
CorrespondentJames M Flaherty
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-12
Decision Date1999-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886704042492 K991222 000
20886704042331 K991222 000
10886704045120 K991222 000
10381780520566 K991222 000
10381780520436 K991222 000

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