TERUMO HOLLOW OXYGENATOR CIRCUIT

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Hollow Oxygenator Circuit.

Pre-market Notification Details

Device IDK812659
510k NumberK812659
Device Name:TERUMO HOLLOW OXYGENATOR CIRCUIT
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-18
Decision Date1981-12-14

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