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FJS — Catheter, Peritoneal, Long-Term Indwelling Class II

FDA Device Classification

Classification Details

Product Code
FJS
Device Class
Class II
Regulation Number
876.5630
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213602covidienArgyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter January 14, 2022
K180485covidienArgyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal DialyJuly 27, 2018
K130441medionics internationalFALLER STYLETApril 19, 2013
K121383medical componentsPS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPSeptember 5, 2012
K120130medigroupFALLER TROCARMay 21, 2012
K113354pfm medicalVETA PERITONEAL DIALYSIS CATHETERMarch 13, 2012
K071167medigroupFLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560August 31, 2007
K070730medigroupFLEX-NECK ARC CATHETERJuly 3, 2007
K060897medigroupEMBEDDING TOOL, MODEL TE-1000July 18, 2006
K053123med-conduitPD CATHMarch 29, 2006
K031351medigroupFLEX-NECK PD CATHETER, INFANTSeptember 17, 2003
K012502janin groupMEDIGROUP CATHETER EXTENDER/REPAIR KITFebruary 4, 2002
K013017janin groupMEDIGROUP KEY TUBEDecember 6, 2001
K993149medionics internationalPERITONEAL DIALYSIS CATHETERS AND ADAPTERSApril 28, 2000
K991042janin groupASH ADVANTAGE PERITONEAL CATHETERJune 25, 1999
K970159janin groupFLEX-NECK PD CATHETERSeptember 5, 1997
K961392sil-medANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT IIJuly 18, 1997
K950042accurate surgical instrumentsSWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETERDecember 15, 1995
K934610tabex industriesCATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERSSeptember 23, 1994
K930175tabex industriesCATH BELT PD CATHETER AND TRANSFER SET HOLDERJune 23, 1994