FKO — Catheter, Peritoneal Dialysis, Single Use Class II

FDA Device Classification

Classification Details

Product Code
FKO
Device Class
Class II
Regulation Number
876.5630
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964514corpakCORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSISJune 26, 1998
K974570medigroupPERITONEAL DIALYSIS CATHETER CONNECTORFebruary 27, 1998
K910787accurate surgical instrumentsTITANIUM CONNECTOR (2 PART)August 15, 1991
K885037bernard j. cooney, p.aAMUKIN 50% - AIRSPRAY(R)October 19, 1990
K874650quintonPERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)December 9, 1987
K872221gesco intlDIALY-NATE SET & DIALY-NATE CATHETEROctober 13, 1987
K871730quintonMODIFIED USE OF PULL-APART INTRODUCER SETMay 18, 1987
K870472quintonACUTE PERITONEAL DIALYSIS KITFebruary 25, 1987
K860155medical componentsPERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8February 14, 1986
K854966thermedicsACUTE PERITONEAL DIALYSIS CATHETERSJanuary 9, 1986
K845041abbott laboratoriesCAPD STAGED CONNECTORFebruary 21, 1985
K813336american pharmaseal div. ahscLAZARUS-NELSON PERITONEAL LAVAGE TRAYDecember 18, 1981
K812717quintonNON-STERILE SHADOW-STRIPE CATHETEROctober 19, 1981
K811266quintonQUINTON CATHETER FINGER GRIPJune 18, 1981
K802954associated medical productsDRESSING CHANGE TRAY-MEDIUMDecember 17, 1980
K760544travenol laboratoriesCATHETER, PERITONEAL DIALYSISOctober 20, 1976