MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)

Apparatus, Autotransfusion

MEDTRONIC BLOOD MANAGEMENT

The following data is part of a premarket notification filed by Medtronic Blood Management with the FDA for Modification Of Autotransfusion Apparatus (autolog).

Pre-market Notification Details

Device IDK982755
510k NumberK982755
Device Name:MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)
ClassificationApparatus, Autotransfusion
Applicant MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker,  CO  80134 -9061
ContactStephen Mckelvey
CorrespondentStephen Mckelvey
MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker,  CO  80134 -9061
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-29
Decision Date1998-08-20
Summary:summary

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