CATSmart, Automated Blood Processing Autotransfusion System

Apparatus, Autotransfusion

Fresenius Kabi AG

The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Catsmart, Automated Blood Processing Autotransfusion System.

Pre-market Notification Details

Device IDK210089
510k NumberK210089
Device Name:CATSmart, Automated Blood Processing Autotransfusion System
ClassificationApparatus, Autotransfusion
Applicant Fresenius Kabi AG Bad Homburg,  DE 61346
ContactDeepak Mehta
CorrespondentCheryl Chamberlain Roscher
Fresenius Kabi Three Corporate Drive Lake Zurich,  IL  60047
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-13
Decision Date2021-02-11

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