FDA 510(k) Applications for Medical Device Product Code "FJS"
(Catheter, Peritoneal, Long-Term Indwelling)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K180485 | Covidien, llc | 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 | 07/27/2018 |
| K213602 | Covidien, llc | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | 01/14/2022 |
| K991042 | JANIN GROUP, INC. | ASH ADVANTAGE PERITONEAL CATHETER | 06/25/1999 |
| K970159 | JANIN GROUP, INC. | FLEX-NECK PD CATHETER | 09/05/1997 |
| K012502 | JANIN GROUP, INC. | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | 02/04/2002 |
| K013017 | JANIN GROUP, INC. | MEDIGROUP KEY TUBE | 12/06/2001 |
| K053123 | MED-CONDUIT, INC. | PD CATH | 03/29/2006 |
| K121383 | MEDICAL COMPONENTS INC | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) | 09/05/2012 |
| K060897 | MEDIGROUP, INC. | EMBEDDING TOOL, MODEL TE-1000 | 07/18/2006 |
| K120130 | MEDIGROUP, INC. | FALLER TROCAR | 05/21/2012 |
| K070730 | MEDIGROUP, INC. | FLEX-NECK ARC CATHETER | 07/03/2007 |
| K071167 | MEDIGROUP, INC. | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | 08/31/2007 |
| K031351 | MEDIGROUP, INC. | FLEX-NECK PD CATHETER, INFANT | 09/17/2003 |
| K130441 | MEDIONICS INTERNATIONAL, INC. | FALLER STYLET | 04/19/2013 |
| K993149 | MEDIONICS INTERNATIONAL, INC. | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | 04/28/2000 |
| K113354 | PFM MEDICAL, INC | VETA PERITONEAL DIALYSIS CATHETER | 03/13/2012 |
| K961392 | SIL-MED CORP. | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | 07/18/1997 |
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