Product code FJS
- Device name
- Catheter, Peritoneal, Long-Term Indwelling
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5630
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | Covidien, LLC | 2022-01-14 |
| K180485 | 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 Exte... | Covidien, LLC | 2018-07-27 |
| K130441 | FALLER STYLET | Medionics International, Inc. | 2013-04-19 |
| K121383 | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) | Medical Components, Inc. | 2012-09-05 |
| K120130 | FALLER TROCAR | Medigroup, Inc. | 2012-05-21 |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Pfm Medical, Inc. | 2012-03-13 |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | Medigroup, Inc. | 2007-08-31 |
| K070730 | FLEX-NECK ARC CATHETER | Medigroup, Inc. | 2007-07-03 |
| K060897 | EMBEDDING TOOL, MODEL TE-1000 | Medigroup, Inc. | 2006-07-18 |
| K053123 | PD CATH | Med-Conduit, Inc. | 2006-03-29 |
| K031351 | FLEX-NECK PD CATHETER, INFANT | Medigroup, Inc. | 2003-09-17 |
| K012502 | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | Janin Group, Inc. | 2002-02-04 |
| K013017 | MEDIGROUP KEY TUBE | Janin Group, Inc. | 2001-12-06 |
| K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | Medionics International, Inc. | 2000-04-28 |
| K991042 | ASH ADVANTAGE PERITONEAL CATHETER | Janin Group, Inc. | 1999-06-25 |
| K970159 | FLEX-NECK PD CATHETER | Janin Group, Inc. | 1997-09-05 |
| K961392 | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | Sil-Med Corp. | 1997-07-18 |
| K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | Accurate Surgical Instruments Co. | 1995-12-15 |
| K934610 | CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS | Tabex Industries, Inc. | 1994-09-23 |
| K930175 | CATH BELT PD CATHETER AND TRANSFER SET HOLDER | Tabex Industries, Inc. | 1994-06-23 |
| K915490 | MEDCOMP PERITONEAL DIALYSIS CATHETERS | Medical Components, Inc. | 1994-02-02 |
| K920515 | INSERTION | Accurate Surgical Instruments Co. | 1992-05-04 |
| K910786 | TROCAR (FALLER STYLET) | Accurate Surgical Instruments Co. | 1991-09-19 |
| K910785 | TITANIUM CATHETER EXTENDER | Accurate Surgical Instruments Co. | 1991-08-22 |
| K903502 | LIFECOIL CATHETER | Lifemed of California | 1990-10-22 |
| K902101 | PERITONEAL CATHETERS | Akcess Medical Products, Inc. | 1990-07-27 |
| K890288 | PERITONEAL CATHETERS WITH AN ADDED FUNCTION | Quinton, Inc. | 1989-03-27 |
| K885167 | TRUDELL BENT CATHETER | Sil-Med Corp. | 1989-01-31 |
| K871817 | VAS-CATH PERITONEAL DIALYSIS CATHETER | Vas-Cath of Canada , Ltd. | 1987-07-16 |
| K863819 | CHEMO-CATH INTRAPERITONEAL CATHETER | Hdc Corp. | 1987-02-04 |
Related GUDID Devices#
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| 10884521852891 | Ritus | Mozarc Medical US LLC | 2025-11-27 |
| 10884521811201 | Ritus | Mozarc Medical US LLC | 2024-10-21 |
| 20884521844046 | Ritus | Mozarc Medical US LLC | 2024-09-16 |
| 20884521844039 | Ritus | Mozarc Medical US LLC | 2024-09-16 |
| 20884521844022 | Ritus | Mozarc Medical US LLC | 2024-09-16 |
| 20884521843520 | Ritus | Mozarc Medical US LLC | 2024-09-16 |
| 10884521004030 | Argyle | Mozarc Medical US LLC | 2016-09-24 |
| 10884521198005 | Argyle | Mozarc Medical US LLC | 2016-04-15 |
| 10884521084537 | Argyle | Mozarc Medical US LLC | 2016-04-15 |
| 10884521084483 | Argyle | Mozarc Medical US LLC | 2016-04-15 |
| 10884521055933 | Argyle | Mozarc Medical US LLC | 2016-04-15 |
| 10884521196094 | Argyle | Mozarc Medical US LLC | 2015-10-06 |
| 10884521056510 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521184411 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521084544 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521084476 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521055858 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521055841 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521055834 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521055827 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521055810 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521055650 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521055513 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521004672 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521004283 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521004276 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521004269 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521004252 | Argyle | Mozarc Medical US LLC | 2015-09-28 |
| 10884521004245 | Argyle | Mozarc Medical US LLC | 2015-09-28 |