SORIN C5 SYSTEM MODEL 58-00-00

Console, Heart-lung Machine, Cardiopulmonary Bypass

SORIN GROUP DEUTSCHLAND GMBH

The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin C5 System Model 58-00-00.

Pre-market Notification Details

Device IDK093882
510k NumberK093882
Device Name:SORIN C5 SYSTEM MODEL 58-00-00
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro,  MA  02760
ContactRosina Robinson, Rn, Med, Rac
CorrespondentRosina Robinson, Rn, Med, Rac
SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-18
Decision Date2010-01-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817901440 K093882 000
04033817901433 K093882 000
04033817901426 K093882 000
04033817900924 K093882 000

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