510(k) Report

Devices descending from K993120

9 later devices reach Modified Blood Recipient Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210335Blood Administration SetBaxter Healthcare Corporation20211—
+1K021293Arteria Blood FilterArteria Medical Science, Inc.20026—
+2K220558Blood Administration SetsBaxter Healthcare Corporation20220—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+3K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+3K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+3K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+4K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+5K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I