STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE

Detector, Bubble, Cardiopulmonary Bypass

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Stockert Caps1 Cardioplegic Control Module.

Pre-market Notification Details

Device IDK925661
510k NumberK925661
Device Name:STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
ClassificationDetector, Bubble, Cardiopulmonary Bypass
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
ContactDavid Taylor
CorrespondentDavid Taylor
SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
Product CodeKRL  
CFR Regulation Number870.4205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-10
Decision Date1993-05-18

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