CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING

Reservoir, Blood, Cardiopulmonary Bypass

SORIN GROUP ITALIA S.R.L.

The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Card 43 Cardiotomy Reservoir With Phosphorylcholine Coating.

Pre-market Notification Details

Device IDK061527
510k NumberK061527
Device Name:CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham,  MA  02451
ContactBarry Sall
CorrespondentBarry Sall
SORIN GROUP ITALIA S.R.L. 200 WEST STREET Waltham,  MA  02451
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-02
Decision Date2006-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178250123 K061527 000

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