Product Code: FJS
FDA class 2
21 CFR 876.5630
Catheter, Peritoneal, Long-Term Indwelling
Gastroenterology, Urology
The Long-Term Indwelling Peritoneal Catheter is a surgically placed device designed to provide continuous or repeated access to the peritoneal cavity for patients undergoing peritoneal dialysis over extended periods. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FJS, regulated under 21 CFR 876.5630 in the Gastroenterology and Urology specialty. This device is flagged as an implant, indicating it is placed within or on the body.
510(k)s
48
FEI Numbers
26
Registration Numbers
26
Unique Applicants
22
Years Active
44
Basic Information
- Product Code
- FJS
- Device Class
- FDA class 2
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 48 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | Jan 14, 2022 | Substantially Equivalent | Covidien, llc |
| 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 | Jul 27, 2018 | Unknown | Covidien, llc |
| K130441 | FALLER STYLET | Apr 19, 2013 | Substantially Equivalent | MEDIONICS INTERNATIONAL, INC. |
| K121383 | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) | Sep 05, 2012 | Unknown | MEDICAL COMPONENTS INC |
| K120130 | FALLER TROCAR | May 21, 2012 | Substantially Equivalent | MEDIGROUP, INC. |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Mar 13, 2012 | Unknown | PFM MEDICAL, INC |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | Aug 31, 2007 | Unknown | MEDIGROUP, INC. |
| K070730 | FLEX-NECK ARC CATHETER | Jul 03, 2007 | Unknown | MEDIGROUP, INC. |
| K060897 | EMBEDDING TOOL, MODEL TE-1000 | Jul 18, 2006 | Substantially Equivalent | MEDIGROUP, INC. |
| K053123 | PD CATH | Mar 29, 2006 | Substantially Equivalent | MED-CONDUIT, INC. |
| K031351 | FLEX-NECK PD CATHETER, INFANT | Sep 17, 2003 | Substantially Equivalent | MEDIGROUP, INC. |
| K012502 | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | Feb 04, 2002 | Substantially Equivalent | JANIN GROUP, INC. |
| K013017 | MEDIGROUP KEY TUBE | Dec 06, 2001 | Substantially Equivalent | JANIN GROUP, INC. |
| K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | Apr 28, 2000 | Substantially Equivalent | MEDIONICS INTERNATIONAL, INC. |
| K991042 | ASH ADVANTAGE PERITONEAL CATHETER | Jun 25, 1999 | Substantially Equivalent | JANIN GROUP, INC. |
| K970159 | FLEX-NECK PD CATHETER | Sep 05, 1997 | Substantially Equivalent | JANIN GROUP, INC. |
| K961392 | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | Jul 18, 1997 | Substantially Equivalent | SIL-MED CORP. |
| K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | Dec 15, 1995 | Substantially Equivalent | ACCURATE SURGICAL INSTRUMENTS CO. |
| K934610 | CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS | Sep 23, 1994 | Substantially Equivalent | TABEX INDUSTRIES, INC. |
| K930175 | CATH BELT PD CATHETER AND TRANSFER SET HOLDER | Jun 23, 1994 | Substantially Equivalent | TABEX INDUSTRIES, INC. |
| K915490 | MEDCOMP PERITONEAL DIALYSIS CATHETERS | Feb 02, 1994 | Unknown | MEDICAL COMPONENTS, INC. |
| K920515 | INSERTION | May 04, 1992 | Substantially Equivalent | ACCURATE SURGICAL INSTRUMENTS CO. |
| K910786 | TROCAR (FALLER STYLET) | Sep 19, 1991 | Substantially Equivalent | ACCURATE SURGICAL INSTRUMENTS CO. |
| K910785 | TITANIUM CATHETER EXTENDER | Aug 22, 1991 | Substantially Equivalent | ACCURATE SURGICAL INSTRUMENTS CO. |
| K903502 | LIFECOIL CATHETER | Oct 22, 1990 | Substantially Equivalent | LIFEMED OF CALIFORNIA |
| K902101 | PERITONEAL CATHETERS | Jul 27, 1990 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K890288 | PERITONEAL CATHETERS WITH AN ADDED FUNCTION | Mar 27, 1989 | Substantially Equivalent | QUINTON, INC. |
| K885167 | TRUDELL BENT CATHETER | Jan 31, 1989 | Substantially Equivalent | SIL-MED CORP. |
| K871817 | VAS-CATH PERITONEAL DIALYSIS CATHETER | Jul 16, 1987 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K863819 | CHEMO-CATH INTRAPERITONEAL CATHETER | Feb 04, 1987 | Substantially Equivalent | HDC CORP. |
| K863128 | PERITONEAL DIALYSIS CATHETERS | Sep 09, 1986 | Substantially Equivalent | THERMEDICS, INC. |
| K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | Jun 19, 1986 | Substantially Equivalent | ACCURATE SURGICAL INSTRUMENTS CO. |
| K854614 | LONG TERM PERITONEAL CATHETER | Dec 19, 1985 | Substantially Equivalent | THERMADICS, INC. |
| K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | Jul 26, 1985 | Substantially Equivalent | ACCURATE SURGICAL INSTRUMENTS CO. |
| K820909 | GORE-TEX PERITONEAL CATHETERR | May 21, 1982 | Substantially Equivalent | W.L. GORE & ASSOCIATES,INC |
| K813488 | CATHETER REGULAR | Dec 31, 1981 | Substantially Equivalent | ACCURATE SURGICAL INSTRUMENTS CO. |
| K812718 | CUFF MATERIAL ON PEDIATRIC SIZE CATH. | Oct 19, 1981 | Substantially Equivalent | QUINTON, INC. |
| K812607 | TENCKHOFF PERITONEAL CATHETERS | Oct 02, 1981 | Substantially Equivalent | QUINTON, INC. |
| K810236 | MIROMED PERITONEAL DIALYSIS CATHETER | Mar 13, 1981 | Substantially Equivalent | AMERICAN MEDICAL PRODUCTS, INC. |
| K801818 | TENCKHOFF CATHETER | Oct 23, 1980 | Substantially Equivalent | SIL-MED CORP. |
| K801679 | BETA-CAP II | Oct 03, 1980 | Substantially Equivalent | QUINTON, INC. |
| K782058 | CATHETER, BETA-CAP-PERITONEAL | Feb 27, 1979 | Substantially Equivalent | DRAVON MEDICAL, INC. |
| K782057 | CATHETER, RADIOPAQUE TENCKHOFF | Feb 27, 1979 | Substantially Equivalent | DRAVON MEDICAL, INC. |
| K780449 | BETA CAP SYSTEM | May 16, 1978 | Substantially Equivalent | QUINTON, INC. |
| K780643 | SHADOW-CATHS | Apr 27, 1978 | Substantially Equivalent | QUINTON, INC. |
| K771555 | PERITONEAL DIALYSIS CATHETER | Nov 28, 1977 | Substantially Equivalent | FLUORO-MOLD CO. |
| K771483 | CATHETER FINGER GRIP | Nov 28, 1977 | Substantially Equivalent | QUINTON, INC. |
| K771420 | BETA-CAP | Nov 28, 1977 | Substantially Equivalent | QUINTON, INC. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.