K-numberK061743
Device nameVENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001
ApplicantMaquet Cardiopulmonary, AG
Product codeDTN
Device classClass II
Decision dateJul 21, 2006
DecisionSubstantially Equivalent
Regulation870.4400
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