POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER

Filter, Prebypass, Cardiopulmonary Bypass

POROUS MEDIA CORP.

The following data is part of a premarket notification filed by Porous Media Corp. with the FDA for Porous Media Dpb30 Series Disposable Pre-bypass Filter.

Pre-market Notification Details

Device IDK990276
510k NumberK990276
Device Name:POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
ClassificationFilter, Prebypass, Cardiopulmonary Bypass
Applicant POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul,  MN  55110
ContactRochelle M Mickschl
CorrespondentRochelle M Mickschl
POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul,  MN  55110
Product CodeKRJ  
CFR Regulation Number870.4280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-28
Decision Date1999-10-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B462DPB3032PES002YV5 K990276 000
B46210210403 K990276 000
B46210210393 K990276 000
B4620302183 K990276 000
B4620170169025 K990276 000
B4620170169013 K990276 000
B4620170169005 K990276 000
B4620008810893 K990276 000
B4620008038383 K990276 000
B4620008038123 K990276 000
B4620008012125 K990276 000
B46210310843 K990276 000
B46210310863 K990276 000
B4623452600003 K990276 000
B462DPB3032PES002YN3 K990276 000
B462DPB3022PES002YN3 K990276 000
B462DPB30223 K990276 000
B4627010310863 K990276 000
B4627010310843 K990276 000
B4627010210403 K990276 000
B4627010210393 K990276 000
B4624724230000013 K990276 000
B4623452800003 K990276 000
B4623452700003 K990276 000
B462DPB3033PES002YN0 K990276 000

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