FDA 510(k) Applications for Medical Device Product Code "KDJ"
(Set, Administration, For Peritoneal Dialysis, Disposable)

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


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