POROUS MEDIA DPB20 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 Dpb20 Series Disposable Pre-bypass Filter.

Pre-market Notification Details

Device IDK982385
510k NumberK982385
Device Name:POROUS MEDIA DPB20 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 Received1998-07-09
Decision Date1999-02-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B462DPC2023S500C5 K982385 000
B4624150002210 K982385 000
B46200080020115 K982385 000
B46200080020125 K982385 000
B46200080020225 K982385 000
B46200080020235 K982385 000
B46200080020335 K982385 000
B4623452900005 K982385 000
B46261255 K982385 000
B46261265 K982385 000
B4627010543855 K982385 000
B4624150002200 K982385 000

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