MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE

Oxygenator, Cardiopulmonary Bypass

SORIN BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Monolyth C 600 And 1200 Hollow Fiber Membrane Lung With Integrated Softshell Venous Reservoir , Cvr 600 And 1200 Softshe.

Pre-market Notification Details

Device IDK990103
510k NumberK990103
Device Name:MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92614 -5751
ContactLynne Leonard
CorrespondentLynne Leonard
SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92614 -5751
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-12
Decision Date1999-11-05
Summary:summary

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