PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS

Oxygenator, 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 Plexus 2 & 3.5 Hollow Fiber Oxygenators.

Pre-market Notification Details

Device IDK931444
510k NumberK931444
Device Name:PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
ContactDavid Taylor
CorrespondentDavid Taylor
SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-22
Decision Date1994-05-27

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