510(k) Report

Devices descending from K191513

2 later devices reach Altapore Shape through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200640Altapore ShapeBaxter Healthcare Corporation20201—
+2K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—