FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K152675 |
BAXTER HEALTHCARE |
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER |
10/29/2015 |
K192705 |
Baxter Healthcare |
MiniCap Extended Life PD Transfer Sets |
10/25/2019 |
K972579 |
BAXTER HEALTHCARE CORP. |
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE |
10/01/1997 |
K031676 |
BAXTER HEALTHCARE CORP. |
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q |
11/20/2003 |
K961825 |
BAXTER HEALTHCARE CORP. |
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 |
08/06/1996 |
K214016 |
Baxter Healthcare Corporation |
15L Cycler Drainage Bag |
03/18/2022 |
K152129 |
BAXTER HEALTHCARE CORPORATION |
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution |
10/29/2015 |
K022412 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR |
03/05/2003 |
K041792 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 |
09/24/2004 |
K083542 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
FRESENIUS STERILE STAY SAFE CAP |
12/29/2008 |
K173363 |
Fresenius Medical Care Renal Therapies Group, LLC |
Cycler Drain Bag Set |
01/24/2018 |
K173651 |
Fresenius Medical Care Renal Therapies Group, LLC |
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set |
02/14/2018 |
K173593 |
Fresenius Medical Care Renal Therapies Group, LLC |
stayòsafe catheter extension set with Safe-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 6 inch, stayòsafe catheter extension set with Luer-Lock, 12 inch, stayòsafe catheter extension set with Luer-Lock, 18 inch, stayòsafe to Luer-Lock a |
05/21/2018 |
K124024 |
FRESENSIUS MEDICAL CARE NORTH AMERICA |
APD LUER-LOCK ADAPTER |
09/19/2013 |
K042900 |
K.E.P., LLC |
K.E.P. CONNECTOR AND CLIP |
11/05/2004 |
K972731 |
KLEIN-BAKER MEDICAL, INC. |
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET |
09/29/1997 |
K963668 |
MEDISYSTEMS CORP. |
MEDISYSTEMS PERITONEAL DIALYSIS SETS |
08/15/1997 |
K974387 |
MICROWAVE MEDICAL SYSTEMS, INC. |
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE |
09/01/1999 |
K151620 |
PURACATH MEDICAL, INC. |
Firefly Peritoneal Dialysis Connector Disinfection System |
01/20/2016 |