BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS

Heat-exchanger, Cardiopulmonary Bypass

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Bcd Advanced Blood Carioplegia Systems.

Pre-market Notification Details

Device IDK925369
510k NumberK925369
Device Name:BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
ContactDonna Free
CorrespondentDonna Free
SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-23
Decision Date1993-03-26

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