510(k) Report

Devices descending from K953823

14 later devices reach Arterial Venous Blood Tubing Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080807Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc.20089Class I
+1K032975JMS Blood Tubing SetsJms North America Corp.20041—
+1K994306ReversoMedisystems Corp.20009—
+2K171952Dimesol Tubing Sets for HemodialysisDimesol, Inc.20180—
+2K172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius Medical Care Renal Therapies Group, LLC20176—
+2K132602Streamline ExpressNxstage Medical, Inc.20140—
+2K090255Blood Tubing Sets (Sterile Fluid Path)Nxstage Medical, Inc.20090—
+2K022536\Resenius Access Flow Reserving Connectors, Fresenius Standalone Accces Flow Reserving…Fresenius Medical Care200273
+3K2315345008X Hemodialysis SystemFresenius Medical Care202421
+3K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…Fresenius Medical Care Renal Therapies Group, LLC20205—
+4K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+4K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC202311
+5K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+5K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.20250—