THE CDI(R) SYSTEM 400

Ion-exchange Chromatography

CARDIOVASCULAR DEVICES, INC.

The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for The Cdi(r) System 400.

Pre-market Notification Details

Device IDK890113
510k NumberK890113
Device Name:THE CDI(R) SYSTEM 400
ClassificationIon-exchange Chromatography
Applicant CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine,  CA  92714
ContactSteven Arick
CorrespondentSteven Arick
CARDIOVASCULAR DEVICES, INC. 2801 BARRANCA Irvine,  CA  92714
Product CodeDJY  
CFR Regulation Number862.2230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-11
Decision Date1989-05-23

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