INTRACRANIAL PRESSURE MONITORING CUP CATHETERS

Device, Monitoring, Intracranial Pressure

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Intracranial Pressure Monitoring Cup Catheters.

Pre-market Notification Details

Device IDK854657
510k NumberK854657
Device Name:INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant CORDIS CORP. P.O. BOX 025700 Miami,  FL  33102
ContactDavid Kornhauser
CorrespondentDavid Kornhauser
CORDIS CORP. P.O. BOX 025700 Miami,  FL  33102
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-11-20
Decision Date1985-12-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M2729101261 K854657 000
M2729101251 K854657 000

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