510(k) Report

Devices descending from K991783

13 later devices reach AB-180 XC System, Model AB-180XC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110493Tandemheart PumpCardiacassist, Inc.201128
+1K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+1K061369Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Cardiacassist, Inc.20064—
+2K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.20191Class I
+2K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+2K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+2K093801Impella ControllerAbiomed, Inc.20101—
+2K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+2K073631Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation20080—
+3K232132LifeSPARC SystemCardiacassist, Inc.20230—
+3K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+3K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+3K110845Impella Controller with Flow ControlAbiomed, Inc.20110—