FJS · Class II · 21 CFR 876.5630

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

Leading manufacturers include Quinton, Inc., Medical Components, Inc. and Covidien, LLC.

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 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 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 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 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
Cleared Nov 28, 1977
BETA-CAP
K771420
Quinton, Inc.
Gastroenterology & Urology · 119d
Cleared Nov 28, 1977
CATHETER FINGER GRIP
K771483
Quinton, Inc.
Gastroenterology & Urology · 116d

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.