510(k) Report

Devices descending from K854511

11 later devices reach Elecath Percutaneous Left Atrial Cannulation Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030398Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc.200310—
+2K082425Tandemheart Transseptal Cannula- EF 72Cardiacassist, Inc.20080—
+2K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc.200691
+3K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+4K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+4K093801Impella ControllerAbiomed, Inc.20101—
+4K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+5K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+5K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+6K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+6K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—