FDA Product Code FJS: Catheter, Peritoneal, Long-term Indwelling
Leading manufacturers include 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
Cleared
Jan 14, 2022
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
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
Covidien, LLC
Gastroenterology & Urology
154d
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.