510(k) Report

Devices descending from K191029

3 later devices reach Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200109OXY-1 SystemAbiomed, Inc.20202Class I
+2K223161OXY-1 SystemAbiomed, Inc.20230—
+2K222297CentriMag Pre-connected PackAbbott20220—