VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR

Reservoir, Blood, Cardiopulmonary Bypass

SORIN BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Venomidicard Infant/ Pediatric Venous Cardiotomy Reservoir.

Pre-market Notification Details

Device IDK941215
510k NumberK941215
Device Name:VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92614 -5751
ContactRonald S Warren
CorrespondentRonald S Warren
SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92614 -5751
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-10
Decision Date1995-05-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178250277 K941215 000
38033178250253 K941215 000

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