DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

SORIN BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Dideco Newborn/infant Arterial Filters: D735 Micro 20 And D736 Micro 40.

Pre-market Notification Details

Device IDK961869
510k NumberK961869
Device Name:DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92713 -9503
ContactSusan J Reimers
CorrespondentSusan J Reimers
SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92713 -9503
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-15
Decision Date1996-08-12

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