CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

Tubes, Gastrointestinal (and Accessories)

VIASYS MEDSYSTEMS

The following data is part of a premarket notification filed by Viasys Medsystems with the FDA for Cortrak Enteral Access Device, Model 20-0900.

Pre-market Notification Details

Device IDK063061
510k NumberK063061
Device Name:CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling,  IL  60090
ContactStephanie Wasielewski
CorrespondentStephanie Wasielewski
VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling,  IL  60090
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-05
Decision Date2007-04-02

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