STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

Catheter, Cannula And Tubing, Vascular, 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 S5 System, Stockert Electrical Venous Occluder (evo).

Pre-market Notification Details

Device IDK082344
510k NumberK082344
Device Name:STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
ClassificationCatheter, Cannula And Tubing, Vascular, 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 CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-15
Decision Date2008-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04033817902799 K082344 000
04033817900801 K082344 000
04033817900504 K082344 000

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