510(k) Report

Devices descending from K050168

15 later devices reach Langston Dual Lumen Pressure Monitoring Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+1K061565Langston Dual Lumen CatheterVascular Solutions, Inc.20066Class I
+2K170544Langston dual lumen catheterVascular Solutions, Inc.20171—
+2K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+2K093801Impella ControllerAbiomed, Inc.20101—
+2K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+2K062877Twin-Pass .023 Dual Access Catheter, Model 5230Vascular Solutions, Inc.20070Class I
+2K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc.20072—
+3K222023RayFlowHexacath20230—
+3K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+3K073585Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905Vascular Solutions, Inc.20081—
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+4K081846Grebset Micro-Introducer Kit, Models 7950, 7951Vascular Solutions, Inc.200901