PREBYPASS FILTER

Filter, Prebypass, Cardiopulmonary Bypass

DELTA MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Prebypass Filter.

Pre-market Notification Details

Device IDK780485
510k NumberK780485
Device Name:PREBYPASS FILTER
ClassificationFilter, Prebypass, Cardiopulmonary Bypass
Applicant DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKRJ  
CFR Regulation Number870.4280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-27
Decision Date1978-04-05

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