510(k) Report

Devices descending from K063723

7 later devices reach Impella Recover LP 2.5 Percutaneous Cardiac Support System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+1K093801Impella ControllerAbiomed, Inc.20101—
+1K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+2K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+2K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+3K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—