510(k) Report

Devices descending from K052570

9 later devices reach Tandemheart Transseptal Cannula Set-EF, Model 5140-6221 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082425Tandemheart Transseptal Cannula- EF 72Cardiacassist, Inc.20080—
+1K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+2K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+2K093801Impella ControllerAbiomed, Inc.20101—
+2K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+3K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—