510(k) Report

Devices descending from K943739

22 later devices reach Softouch Diagnostic Intravascular Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143604Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic…Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S20150—
+1K113819Mongoose Angiographic CatheterPediacath, Inc.20121—
+1K051395Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc.20058Class I
+1K050168Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc.200515—
+1K041909Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc.20047—
+2K221470Langston dual lumen catheterVascular Solutions, LLC20220—
+2K171264Royal Flush CatheterCook Incorporated20180—
+2K170544Langston dual lumen catheterVascular Solutions, Inc.20171—
+2K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc.20087—
+2K061565Langston Dual Lumen CatheterVascular Solutions, Inc.20066Class I
+3K222023RayFlowHexacath20230—
+3K112892Impella 2.5 Plus CatheterAbiomed, Inc.20120—
+3K093801Impella ControllerAbiomed, Inc.20101—
+3K083111Impella 5.0 Catheter FamilyAbiomed, Inc.200931
+3K062877Twin-Pass .023 Dual Access Catheter, Model 5230Vascular Solutions, Inc.20070Class I
+3K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc.20072—
+4K110845Impella Controller with Flow ControlAbiomed, Inc.20110—
+4K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+4K073585Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905Vascular Solutions, Inc.20081—
+5K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+5K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+5K081846Grebset Micro-Introducer Kit, Models 7950, 7951Vascular Solutions, Inc.200901