OCS Lung Donor Flush Set

System And Accessories, Isolated Heart, Transport And Preservation

TransMedics, Inc.

The following data is part of a premarket notification filed by Transmedics, Inc. with the FDA for Ocs Lung Donor Flush Set.

Pre-market Notification Details

Device IDK222535
510k NumberK222535
Device Name:OCS Lung Donor Flush Set
ClassificationSystem And Accessories, Isolated Heart, Transport And Preservation
Applicant TransMedics, Inc. 200 Minuteman Road Suite 302 Andover,  MA  01810
ContactMiriam Provost
CorrespondentMiriam Provost
TransMedics, Inc. 200 Minuteman Road Suite 302 Andover,  MA  01810
Product CodeMSB  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-22
Decision Date2022-11-18

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