FJS · Class II · 21 CFR 876.5630

FDA Product Code FJS: Catheter, Peritoneal, Long-term Indwelling

Leading manufacturers include Quinton, Inc., Sil-Med Corp. and Medical Components, Inc..

48
Total
48
Cleared
139d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Catheter, Peritoneal, Long-term Indwelling Devices (Product Code FJS)

48 devices
1–24 of 48
Cleared Jan 14, 2022
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
K213602
Covidien, LLC
Gastroenterology & Urology · 60d
Cleared Jul 27, 2018
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
K180485
Covidien, LLC
Gastroenterology & Urology · 154d
Cleared Apr 19, 2013
FALLER STYLET
K130441
Medionics International, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 05, 2012
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
K121383
Medical Components, Inc.
Gastroenterology & Urology · 120d
Cleared May 21, 2012
FALLER TROCAR
K120130
Medigroup, Inc.
Gastroenterology & Urology · 125d
Cleared Mar 13, 2012
VETA PERITONEAL DIALYSIS CATHETER
K113354
Pfm Medical, Inc.
Gastroenterology & Urology · 120d
Cleared Apr 28, 2000
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
K993149
Medionics International, Inc.
Gastroenterology & Urology · 220d
Cleared Jun 25, 1999
ASH ADVANTAGE PERITONEAL CATHETER
K991042
Janin Group, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 05, 1997
FLEX-NECK PD CATHETER
K970159
Janin Group, Inc.
Gastroenterology & Urology · 232d
Cleared Jul 18, 1997
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392
Sil-Med Corp.
Gastroenterology & Urology · 463d
Cleared Feb 02, 1994
MEDCOMP PERITONEAL DIALYSIS CATHETERS
K915490
Medical Components, Inc.
Gastroenterology & Urology · 789d
Cleared Jul 27, 1990
PERITONEAL CATHETERS
K902101
Akcess Medical Products, Inc.
Gastroenterology & Urology · 80d
Cleared Mar 27, 1989
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288
Quinton, Inc.
Gastroenterology & Urology · 67d
Cleared Jan 31, 1989
TRUDELL BENT CATHETER
K885167
Sil-Med Corp.
Gastroenterology & Urology · 49d
Cleared Jul 16, 1987
VAS-CATH PERITONEAL DIALYSIS CATHETER
K871817
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 66d
Cleared Feb 04, 1987
CHEMO-CATH INTRAPERITONEAL CATHETER
K863819
Hdc Corp.
Gastroenterology & Urology · 127d
Cleared May 21, 1982
GORE-TEX PERITONEAL CATHETERR
K820909
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 19, 1981
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718
Quinton, Inc.
Gastroenterology & Urology · 24d
Cleared Oct 02, 1981
TENCKHOFF PERITONEAL CATHETERS
K812607
Quinton, Inc.
Gastroenterology & Urology · 17d
Cleared Mar 13, 1981
MIROMED PERITONEAL DIALYSIS CATHETER
K810236
American Medical Products, Inc.
Gastroenterology & Urology · 45d
Cleared Oct 23, 1980
TENCKHOFF CATHETER
K801818
Sil-Med Corp.
Gastroenterology & Urology · 84d
Cleared Oct 03, 1980
BETA-CAP II
K801679
Quinton, Inc.
Gastroenterology & Urology · 73d
Cleared May 16, 1978
BETA CAP SYSTEM
K780449
Quinton, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 27, 1978
SHADOW-CATHS
K780643
Quinton, Inc.
Gastroenterology & Urology · 10d

About Product Code FJS - Regulatory Context

510(k) Submission Activity

48 total 510(k) submissions under product code FJS since 1977, with 48 receiving FDA clearance (average review time: 139 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.