ARTERIAL BUBBLE TRAP K-20

Detector, Bubble, Cardiopulmonary Bypass

DELTA MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Arterial Bubble Trap K-20.

Pre-market Notification Details

Device IDK803102
510k NumberK803102
Device Name:ARTERIAL BUBBLE TRAP K-20
ClassificationDetector, Bubble, Cardiopulmonary Bypass
Applicant DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKRL  
CFR Regulation Number870.4205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-09
Decision Date1980-12-22

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