Product Code: LFJ
FDA class 2
21 CFR 876.5540
Catheter, Subclavian
Gastroenterology, Urology
A subclavian catheter is a vascular access device inserted through the subclavian vein to provide long-term intravenous access for the administration of fluids, medications, blood products, or parenteral nutrition, or for hemodynamic monitoring. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LFJ and is regulated under 21 CFR 876.5540 within the Gastroenterology and Urology specialty. This device is flagged as an implant, as it is placed within the body for the duration of use.
510(k)s
65
FEI Numbers
27
Registration Numbers
27
Unique Applicants
22
Years Active
14
Basic Information
- Product Code
- LFJ
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- 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
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Related 510(k) Clearances
This FDA classification is associated with 65 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920780 | MEDSURG INSERTION TRAY | Aug 19, 1994 | Unknown | MEDSURG INDUSTRIES, INC. |
| K925819 | AKCESS0CATH KIT | Aug 02, 1994 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K925818 | AKCESS-CATH | Apr 05, 1994 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K913468 | ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY | Mar 24, 1994 | Substantially Equivalent | COOK, INC. |
| K931120 | COAXIAL ACUTE CATHETER | Jan 14, 1994 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K920634 | SPLITTABLE SHEATH INTRODUCER SET | Jan 14, 1994 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K914162 | VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS | Jul 01, 1993 | Substantially Equivalent | VAS-CATH, INC. |
| K915423 | HEMO-CATH SILICONE ACCESS CATHETER | Feb 02, 1993 | Unknown | MEDICAL COMPONENTS, INC. |
| K914826 | AKCESS-CATH KIT | Apr 10, 1992 | Unknown | AKCESS MEDICAL PRODUCTS, INC. |
| K910501 | PERMANENT SILICONE CATHETERS | Apr 29, 1991 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K905080 | MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER | Jan 31, 1991 | Substantially Equivalent | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
| K904139 | SINGLE LUMEN CATHETER KITS | Dec 04, 1990 | Unknown | AKCESS MEDICAL PRODUCTS, INC. |
| K904140 | SINGLE LUMEN CATHETERS, MODIFICATION | Nov 27, 1990 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K901133 | DURACATH | Jun 08, 1990 | Substantially Equivalent | IMPRA, INC. |
| K901061 | SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000 | May 22, 1990 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K900835 | MODIFIED PERM-CATH | May 09, 1990 | Substantially Equivalent | QUINTON, INC. |
| K896568 | DUALYSE-CATH - CODES #1132.212, 1132.112 | May 09, 1990 | Substantially Equivalent | VYGON CORP. |
| K900803 | DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S | Apr 25, 1990 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K895506 | FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER | Feb 09, 1990 | Substantially Equivalent | VAS-CATH, INC. |
| K895417 | ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT | Jan 03, 1990 | Substantially Equivalent | ARROW INTL., INC. |
| K893439 | HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C | Jun 13, 1989 | Substantially Equivalent | MEDICAL COMPONENTS, INC. |
| K891755 | DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K | Jun 08, 1989 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K891753 | DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 | Jun 08, 1989 | Substantially Equivalent | AKCESS MEDICAL PRODUCTS, INC. |
| K884322 | SUBCLAVIAN HEMODIALYSIS CATHETER | Apr 25, 1989 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K890029 | HEMO-CATH SILICONE DOUBLE LUMEN CATHETER | Apr 17, 1989 | Substantially Equivalent | MEDICAL COMPONENTS, INC. |
| K890099 | MODIFIED VAS-CATH CATHETER REPAIR KIT | Apr 11, 1989 | Substantially Equivalent | VAS-CATH, INC. |
| K883592 | IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER | Dec 08, 1988 | Unknown | IMPRA, INC. |
| K883768 | VAS-CATH CATHETER REPAIR KIT | Nov 14, 1988 | Substantially Equivalent | VAS-CATH, INC. |
| K880778 | MEDSURG ACUTE DIALYSIS TRAY | Jul 15, 1988 | Substantially Equivalent | MEDSURG INDUSTRIES, INC. |
| K881743 | VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER | Jun 23, 1988 | Substantially Equivalent | VAS-CATH, INC. |
| K881695 | DESERET SUBCLAVIAN HEMODIALYSIS CATHETER | Jun 23, 1988 | Substantially Equivalent | DESERET MEDICAL, INC. |
| K881290 | MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA | Apr 27, 1988 | Substantially Equivalent | SHILEY, INC. |
| K875188 | LUER LOCK CONNECTORS / RIDIG P.V.C. | Mar 02, 1988 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K874633 | PERMCATH INSERTION TRAY | Feb 17, 1988 | Unknown | QUINTON, INC. |
| K871942 | PERM-CATH CATHETER KIT | Jun 17, 1987 | Substantially Equivalent | QUINTON, INC. |
| K871749 | ADULT PERM-CATH 40CM. | Jun 17, 1987 | Substantially Equivalent | QUINTON, INC. |
| K871488 | VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH | Jun 12, 1987 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K871487 | VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH | Jun 12, 1987 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K870328 | SINGLE LUMEN ACUTE CATHETER | May 11, 1987 | Substantially Equivalent | QUINTON, INC. |
| K863697 | MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA | Oct 02, 1986 | Substantially Equivalent | SHILEY, INC. |
| K861174 | SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA | Apr 23, 1986 | Substantially Equivalent | SHILEY, INC. |
| K860094 | HURWITZ DIALYSIS CATHETER | Apr 07, 1986 | Substantially Equivalent | GISH BIOMEDICAL, INC. |
| K853283 | VACCESS TM 4006 | Aug 22, 1985 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K852070 | SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL | Jun 13, 1985 | Substantially Equivalent | SHILEY, INC. |
| K852162 | MNI 400 INJECTION CAPS | Jun 12, 1985 | Substantially Equivalent | MED-WEST, INC. |
| K844434 | VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH | Mar 13, 1985 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K844433 | VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA | Mar 13, 1985 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K844336 | VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH | Mar 13, 1985 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K840197 | SINGLE LUMEN SUBCLAVIAN CANNULA | Apr 25, 1984 | Substantially Equivalent | SHILEY, INC. |
| K833848 | DUAL LUMEN SUBCLAVIAN CANNULA | Dec 08, 1983 | Substantially Equivalent | SHILEY, INC. |
| K830438 | MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM | Mar 17, 1983 | Substantially Equivalent | MED COMP |
| K823135 | DOUBLE LUMEN SUBCLAVIAN CATHETER | Mar 07, 1983 | Substantially Equivalent | ABBOTT LABORATORIES |
| K822964 | RIGHT ATRIAL CATHETER | Nov 30, 1982 | Substantially Equivalent | QUINTON, INC. |
| K822910 | RIGHT ARTERIAL CATHETER | Nov 29, 1982 | Substantially Equivalent | QUINTON, INC. |
| K822134 | SHIELY DUEL LUMEN SUBCLAVIAN CANNULA | Aug 03, 1982 | Substantially Equivalent | SHILEY, INC. |
| K821001 | MCPARLAND SCALP VEIN CATHETER | Jul 22, 1982 | Substantially Equivalent | RENAL SYSTEMS, INC. |
| K821955 | MCSCK638 CATHETER IN A TRAY (KIT) | Jul 14, 1982 | Substantially Equivalent | MED COMP |
| K821954 | MCSCK838 CATHETER IN A TRAY (KIT) | Jul 14, 1982 | Substantially Equivalent | MED COMP |
| K821684 | MCSCP8PS WITH 'Y' HUB | Jun 24, 1982 | Substantially Equivalent | MEDICAL COMPONENTS, INC. |
| K821400 | MAHURKAR SUBCLAVIAN CATHETER | Jun 23, 1982 | Substantially Equivalent | QUINTON, INC. |
| K821012 | H-H ALIMENTATION CATHETERS | May 28, 1982 | Substantially Equivalent | HOLTER-HAUSNER INTL. |
| K820238 | COBE ACUFLEX SSN, #15-220 | Mar 10, 1982 | Substantially Equivalent | COBE LABORATORIES, INC. |
| K812326 | SORENSON SUBCLAVIAN CATHETER SSC-8 | Sep 25, 1981 | Substantially Equivalent | SORENSEN RESEARCH |
| K810745 | DOUBLE LUMEN SUBCLAVIN CATHETER SC-400 | Mar 31, 1981 | Substantially Equivalent | VAS-CATH OF CANADA LTD. |
| K801672 | MEDCOMP SUBCLAVIAN CATHETER | Dec 18, 1980 | Substantially Equivalent | MEDICAL COMPONENTS, INC. |
FEI Numbers
This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.