510(k) Report

Devices descending from K030398

10 later devices reach Cardiacassist Transseptal Cannula Set, Model 5132-6221 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082425Tandemheart Transseptal Cannula- EF 72Cardiacassist, Inc.20080—
+1K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc.200691
+2K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+3K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+3K093801Impella ControllerAbiomed, Inc.20101—
+3K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+4K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+4K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+5K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+5K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—