510(k) Report

Devices descending from K780953

14 later devices reach Model 1861 Blood Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc.200013—
+2K110493Tandemheart PumpCardiacassist, Inc.201128
+2K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+2K061369Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500Cardiacassist, Inc.20064—
+3K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc.20191Class I
+3K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+3K093801Impella ControllerAbiomed, Inc.20101—
+3K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+3K073631Orqis Extracorporeal Blood Pumping System, Model BPS-100Orqis Medical Corporation20080—
+4K232132LifeSPARC SystemCardiacassist, Inc.20230—
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+4K110845Impella Controller with Flow ControlAbiomed, Inc.20110—