OXY-1 System

Oxygenator, Cardiopulmonary Bypass

Abiomed Inc.

The following data is part of a premarket notification filed by Abiomed Inc. with the FDA for Oxy-1 System.

Pre-market Notification Details

Device IDK200109
510k NumberK200109
Device Name:OXY-1 System
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant Abiomed Inc. 22 Cherry Hill Drive Danvers,  MA  01923
ContactSteve Orwig
CorrespondentKen Ryder
Abiomed Inc. 22 Cherry Hill Drive Danvers,  MA  01923
Product CodeDTZ  
Subsequent Product CodeDWA
Subsequent Product CodeDWF
Subsequent Product CodeKFM
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-17
Decision Date2020-10-23

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