FJS — Catheter, Peritoneal, Long-Term Indwelling Class II
FDA product code FJS covers "Catheter, Peritoneal, Long-Term Indwelling", a Class II medical device regulated under 21 CFR 876.5630. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213602 | covidien | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter | January 14, 2022 |
| K180485 | covidien | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialy | July 27, 2018 |
| K130441 | medionics international | FALLER STYLET | April 19, 2013 |
| K121383 | medical components | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMP | September 5, 2012 |
| K120130 | medigroup | FALLER TROCAR | May 21, 2012 |
| K113354 | pfm medical | VETA PERITONEAL DIALYSIS CATHETER | March 13, 2012 |
| K071167 | medigroup | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | August 31, 2007 |
| K070730 | medigroup | FLEX-NECK ARC CATHETER | July 3, 2007 |
| K060897 | medigroup | EMBEDDING TOOL, MODEL TE-1000 | July 18, 2006 |
| K053123 | med-conduit | PD CATH | March 29, 2006 |
| K031351 | medigroup | FLEX-NECK PD CATHETER, INFANT | September 17, 2003 |
| K012502 | janin group | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | February 4, 2002 |
| K013017 | janin group | MEDIGROUP KEY TUBE | December 6, 2001 |
| K993149 | medionics international | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | April 28, 2000 |
| K991042 | janin group | ASH ADVANTAGE PERITONEAL CATHETER | June 25, 1999 |
| K970159 | janin group | FLEX-NECK PD CATHETER | September 5, 1997 |
| K961392 | sil-med | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | July 18, 1997 |
| K950042 | accurate surgical instruments | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | December 15, 1995 |
| K934610 | tabex industries | CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS | September 23, 1994 |
| K930175 | tabex industries | CATH BELT PD CATHETER AND TRANSFER SET HOLDER | June 23, 1994 |