INTERSEPT* OXYGEN GAS LINE FILTER

Device, Vascular, For Promoting Embolization

MEDTRONIC BLOOD SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK882136
510k NumberK882136
Device Name:INTERSEPT* OXYGEN GAS LINE FILTER
ClassificationDevice, Vascular, For Promoting Embolization
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 CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-20
Decision Date1988-08-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20673978555564 K882136 000

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