INTERSEPT*PREBYPASS FILTER

Filter, Prebypass, Cardiopulmonary Bypass

MEDTRONIC BLOOD SYSTEMS, INC.

The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Intersept*prebypass Filter.

Pre-market Notification Details

Device IDK883086
510k NumberK883086
Device Name:INTERSEPT*PREBYPASS FILTER
ClassificationFilter, Prebypass, Cardiopulmonary Bypass
Applicant MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim,  CA  92807
ContactDennie W Dyer
CorrespondentDennie W Dyer
MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim,  CA  92807
Product CodeKRJ  
CFR Regulation Number870.4280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-21
Decision Date1988-09-16

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