510(k) Report

Devices descending from K081997

8 later devices reach Perfadex with Tham through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091989Perfadex and Perfadex with ThamXvivo Perfusion AB20107—
+2K240650LungProtectTraferox Technologies, Inc.20241—
+2K202652Servator P SALF Solution with THAMS.A.L.F. Spa20210—
+2K170826Perfadex PlusXvivo Perfusion AB20182—
+2K153384Low Potassium Dextran Solution with Tris DiluentUnited Therapeutics Corporation20160—
+3K261644Perfadex PlusXvivo Perfusion AB20260—
+3K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.20250—
+3K230193Servator P Plus SALF SolutionS.A.L.F. Spa20230—