FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K952631 |
B. BRAUN MEDICAL, INC. |
BRAUN HEMODIALYSIS BLOOD CIRCUITS |
04/30/1996 |
K161582 |
Bain Medical Equipment (Guangzhou) Co., Ltd |
DORA Tubing Sets for Hemodialysis |
06/16/2017 |
K201866 |
Bain Medical Equipment(Guangzhou) Co., Ltd. |
NovaLine Tubing Sets for Hemodialysis |
03/10/2021 |
K013634 |
BIOTEQUE CORP. |
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK |
07/09/2002 |
K992930 |
BIOTEQUE CORP. |
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET |
02/09/2000 |
K171952 |
Dimesol, Inc. |
Dimesol Tubing Sets for Hemodialysis |
03/30/2018 |
K063293 |
EDWARDS LIFESCIENCES SERVICES GMBH |
EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE |
03/23/2007 |
K992039 |
EXELINT INTL. CO. |
EXEL I.V. BLOOD LINE SET |
02/10/2000 |
K012242 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS |
08/16/2001 |
K001107 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) |
06/23/2000 |
K000451 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 |
05/09/2000 |
K001873 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 |
07/28/2000 |
K120823 |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS |
06/15/2012 |
K213992 |
Fresenius Medical Care Renal Therapies Group, LLC |
CombiSet Hemodialysis Blood Tubing Set |
05/31/2023 |
K070414 |
GAMBRO RENAL PRODUCTS |
GAMBRO CARTRIDGE BLOOD SETS |
10/12/2007 |
K063290 |
GAMBRO RENAL PRODUCTS |
GAMBRO QUICKSET BLOODLINES |
01/30/2007 |
K100364 |
GAMBRO RENAL PRODUCTS, INC. |
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 |
11/03/2010 |
K982340 |
HAIDYLENA MEDICAL EGYPT |
EXTRACORPOREAL BLOOD CIRCUIT |
04/30/1999 |
K140841 |
HOME DIALYSIS PLUS |
TABLO CARTRIDGE |
09/11/2014 |
K983559 |
ICU MEDICAL, INC. |
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR |
12/24/1998 |
K202796 |
Jiangxi Sanxin Medtec Co., Ltd. |
SANSIN Tubing Sets for Hemodialysis |
09/06/2021 |
K032975 |
JMS NORTH AMERICA CORP. |
JMS BLOOD TUBING SETS |
08/16/2004 |
K953823 |
MEDISYSTEMS CORP. |
ARTERIAL VENOUS BLOOD TUBING SET |
09/23/1996 |
K971687 |
NATIONAL MEDICAL CARE, INC. |
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME |
07/29/1997 |
K971313 |
NATIONAL MEDICAL CARE, INC. |
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET |
10/27/1997 |
K962081 |
NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC. |
COMBILINES HEMODIALYSIS BLOOD TUBING SET |
11/01/1996 |
K072024 |
NIPRO MEDICAL CORP. |
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 |
10/04/2007 |
K112628 |
NIPRO MEDICAL CORPORATION |
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET |
09/28/2012 |
K080807 |
NXSTAGE MEDICAL, INC. |
BLOOD TUBING SETS (STERILE FLUID PATH) |
07/18/2008 |
K090255 |
NXSTAGE MEDICAL, INC. |
BLOOD TUBING SETS (STERILE FLUID PATH) |
02/10/2009 |
K210782 |
Outset Medical, Inc. |
Tablo Cartridge |
11/26/2021 |
K150304 |
Oxyless Ltd |
Oxyless Blood Tubing Set |
02/24/2016 |
K014140 |
SUNDER BIOMEDICAL TECH. CO., LTD. |
RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET |
11/18/2002 |