FDA Product Code
FDA Product Code FJS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5630
510(k) Clearances — 48 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | Covidien, LLC | 2022-01-14 | Traditional | PDF ↗ |
| 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 Extender | Covidien, LLC | 2018-07-27 | Traditional | PDF ↗ |
| K130441 | FALLER STYLET | Medionics International, Inc. | 2013-04-19 | Traditional | PDF ↗ |
| K121383 | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) | Medical Components, Inc. | 2012-09-05 | Traditional | PDF ↗ |
| K120130 | FALLER TROCAR | Medigroup, Inc. | 2012-05-21 | Traditional | PDF ↗ |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Pfm Medical, Inc. | 2012-03-13 | Traditional | PDF ↗ |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | Medigroup, Inc. | 2007-08-31 | Traditional | PDF ↗ |
| K070730 | FLEX-NECK ARC CATHETER | Medigroup, Inc. | 2007-07-03 | Traditional | PDF ↗ |
| K060897 | EMBEDDING TOOL, MODEL TE-1000 | Medigroup, Inc. | 2006-07-18 | Traditional | PDF ↗ |
| K053123 | PD CATH | Med-Conduit, Inc. | 2006-03-29 | Traditional | PDF ↗ |
| K031351 | FLEX-NECK PD CATHETER, INFANT | Medigroup, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K012502 | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | Janin Group, Inc. | 2002-02-04 | Traditional | PDF ↗ |
| K013017 | MEDIGROUP KEY TUBE | Janin Group, Inc. | 2001-12-06 | Traditional | PDF ↗ |
| K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | Medionics International, Inc. | 2000-04-28 | Traditional | PDF ↗ |
| K991042 | ASH ADVANTAGE PERITONEAL CATHETER | Janin Group, Inc. | 1999-06-25 | Traditional | PDF ↗ |
| K970159 | FLEX-NECK PD CATHETER | Janin Group, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K961392 | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | Sil-Med Corp. | 1997-07-18 | Traditional | PDF ↗ |
| K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | Accurate Surgical Instruments Co. | 1995-12-15 | Traditional | PDF ↗ |
| K934610 | CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS | Tabex Industries, Inc. | 1994-09-23 | Traditional | PDF ↗ |
| K930175 | CATH BELT PD CATHETER AND TRANSFER SET HOLDER | Tabex Industries, Inc. | 1994-06-23 | Traditional | PDF ↗ |
| K915490 | MEDCOMP PERITONEAL DIALYSIS CATHETERS | Medical Components, Inc. | 1994-02-02 | Traditional | PDF ↗ |
| K920515 | INSERTION | Accurate Surgical Instruments Co. | 1992-05-04 | Traditional | PDF ↗ |
| K910786 | TROCAR (FALLER STYLET) | Accurate Surgical Instruments Co. | 1991-09-19 | Traditional | PDF ↗ |
| K910785 | TITANIUM CATHETER EXTENDER | Accurate Surgical Instruments Co. | 1991-08-22 | Traditional | PDF ↗ |
| K903502 | LIFECOIL CATHETER | Lifemed of California | 1990-10-22 | Traditional | PDF ↗ |
| K902101 | PERITONEAL CATHETERS | Akcess Medical Products, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K890288 | PERITONEAL CATHETERS WITH AN ADDED FUNCTION | Quinton, Inc. | 1989-03-27 | Traditional | PDF ↗ |
| K885167 | TRUDELL BENT CATHETER | Sil-Med Corp. | 1989-01-31 | Traditional | PDF ↗ |
| K871817 | VAS-CATH PERITONEAL DIALYSIS CATHETER | Vas-Cath of Canada , Ltd. | 1987-07-16 | Traditional | PDF ↗ |
| K863819 | CHEMO-CATH INTRAPERITONEAL CATHETER | Hdc Corp. | 1987-02-04 | Traditional | PDF ↗ |
| K863128 | PERITONEAL DIALYSIS CATHETERS | Thermedics, Inc. | 1986-09-09 | Traditional | PDF ↗ |
| K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | Accurate Surgical Instruments Co. | 1986-06-19 | Traditional | PDF ↗ |
| K854614 | LONG TERM PERITONEAL CATHETER | Thermadics, Inc. | 1985-12-19 | Traditional | PDF ↗ |
| K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | Accurate Surgical Instruments Co. | 1985-07-26 | Traditional | PDF ↗ |
| K820909 | GORE-TEX PERITONEAL CATHETERR | W. L. Gore & Associates, Inc. | 1982-05-21 | Traditional | PDF ↗ |
| K813488 | CATHETER REGULAR | Accurate Surgical Instruments Co. | 1981-12-31 | Traditional | PDF ↗ |
| K812718 | CUFF MATERIAL ON PEDIATRIC SIZE CATH. | Quinton, Inc. | 1981-10-19 | Traditional | PDF ↗ |
| K812607 | TENCKHOFF PERITONEAL CATHETERS | Quinton, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K810236 | MIROMED PERITONEAL DIALYSIS CATHETER | American Medical Products, Inc. | 1981-03-13 | Traditional | PDF ↗ |
| K801818 | TENCKHOFF CATHETER | Sil-Med Corp. | 1980-10-23 | Traditional | PDF ↗ |
| K801679 | BETA-CAP II | Quinton, Inc. | 1980-10-03 | Traditional | PDF ↗ |
| K782058 | CATHETER, BETA-CAP-PERITONEAL | Dravon Medical, Inc. | 1979-02-27 | Traditional | PDF ↗ |
| K782057 | CATHETER, RADIOPAQUE TENCKHOFF | Dravon Medical, Inc. | 1979-02-27 | Traditional | PDF ↗ |
| K780449 | BETA CAP SYSTEM | Quinton, Inc. | 1978-05-16 | Traditional | PDF ↗ |
| K780643 | SHADOW-CATHS | Quinton, Inc. | 1978-04-27 | Traditional | PDF ↗ |
| K771483 | CATHETER FINGER GRIP | Quinton, Inc. | 1977-11-28 | Traditional | PDF ↗ |
| K771420 | BETA-CAP | Quinton, Inc. | 1977-11-28 | Traditional | PDF ↗ |
| K771555 | PERITONEAL DIALYSIS CATHETER | Fluoro-Mold Co. | 1977-11-28 | Traditional | PDF ↗ |
Product code FJS · Class II · Gastroenterology, Urology. Data: openFDA.