STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55

Control, Pump Speed, 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 Stockert Centrifugal Pump Plus System (scp Plus), Models 60-00-10, 60-00-55.

Pre-market Notification Details

Device IDK091008
510k NumberK091008
Device Name:STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
ClassificationControl, Pump Speed, Cardiopulmonary Bypass
Applicant SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro,  MA  02760
ContactRosina Robinson
CorrespondentRosina Robinson
SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeDWA  
CFR Regulation Number870.4380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-09
Decision Date2009-07-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817901457 K091008 000
04033817900962 K091008 000

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