FDA Product Code
FDA Product Code LFJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5540
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K920780 | MEDSURG INSERTION TRAY | Medsurg Industries, Inc. | 1994-08-19 | Traditional | PDF ↗ |
| K925819 | AKCESS0CATH KIT | Akcess Medical Products, Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K925818 | AKCESS-CATH | Akcess Medical Products, Inc. | 1994-04-05 | Traditional | PDF ↗ |
| K913468 | ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY | Cook, Inc. | 1994-03-24 | Traditional | PDF ↗ |
| K920634 | SPLITTABLE SHEATH INTRODUCER SET | Akcess Medical Products, Inc. | 1994-01-14 | Traditional | PDF ↗ |
| K931120 | COAXIAL ACUTE CATHETER | Akcess Medical Products, Inc. | 1994-01-14 | Traditional | PDF ↗ |
| K914162 | VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS | Vas-Cath, Inc. | 1993-07-01 | Traditional | PDF ↗ |
| K915423 | HEMO-CATH SILICONE ACCESS CATHETER | Medical Components, Inc. | 1993-02-02 | Traditional | PDF ↗ |
| K914826 | AKCESS-CATH KIT | Akcess Medical Products, Inc. | 1992-04-10 | Traditional | PDF ↗ |
| K910501 | PERMANENT SILICONE CATHETERS | Akcess Medical Products, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K905080 | MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1991-01-31 | Traditional | PDF ↗ |
| K904139 | SINGLE LUMEN CATHETER KITS | Akcess Medical Products, Inc. | 1990-12-04 | Traditional | PDF ↗ |
| K904140 | SINGLE LUMEN CATHETERS, MODIFICATION | Akcess Medical Products, Inc. | 1990-11-27 | Traditional | PDF ↗ |
| K901133 | DURACATH | Impra, Inc. | 1990-06-08 | Traditional | PDF ↗ |
| K901061 | SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000 | Akcess Medical Products, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K900835 | MODIFIED PERM-CATH | Quinton, Inc. | 1990-05-09 | Traditional | PDF ↗ |
| K896568 | DUALYSE-CATH - CODES #1132.212, 1132.112 | Vygon Corp. | 1990-05-09 | Traditional | PDF ↗ |
| K900803 | DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S | Akcess Medical Products, Inc. | 1990-04-25 | Traditional | PDF ↗ |
| K895506 | FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER | Vas-Cath, Inc. | 1990-02-09 | Traditional | PDF ↗ |
| K895417 | ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT | Arrow Intl., Inc. | 1990-01-03 | Traditional | PDF ↗ |
| K893439 | HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C | Medical Components, Inc. | 1989-06-13 | Traditional | PDF ↗ |
| K891753 | DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800 | Akcess Medical Products, Inc. | 1989-06-08 | Traditional | PDF ↗ |
| K891755 | DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K | Akcess Medical Products, Inc. | 1989-06-08 | Traditional | PDF ↗ |
| K884322 | SUBCLAVIAN HEMODIALYSIS CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-04-25 | Traditional | PDF ↗ |
| K890029 | HEMO-CATH SILICONE DOUBLE LUMEN CATHETER | Medical Components, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K890099 | MODIFIED VAS-CATH CATHETER REPAIR KIT | Vas-Cath, Inc. | 1989-04-11 | Traditional | PDF ↗ |
| K883592 | IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER | Impra, Inc. | 1988-12-08 | Traditional | PDF ↗ |
| K883768 | VAS-CATH CATHETER REPAIR KIT | Vas-Cath, Inc. | 1988-11-14 | Traditional | PDF ↗ |
| K880778 | MEDSURG ACUTE DIALYSIS TRAY | Medsurg Industries, Inc. | 1988-07-15 | Traditional | PDF ↗ |
| K881695 | DESERET SUBCLAVIAN HEMODIALYSIS CATHETER | Deseret Medical, Inc. | 1988-06-23 | Traditional | PDF ↗ |
| K881743 | VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER | Vas-Cath, Inc. | 1988-06-23 | Traditional | PDF ↗ |
| K881290 | MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1988-04-27 | Traditional | PDF ↗ |
| K875188 | LUER LOCK CONNECTORS / RIDIG P.V.C. | Vas-Cath of Canada , Ltd. | 1988-03-02 | Traditional | PDF ↗ |
| K874633 | PERMCATH INSERTION TRAY | Quinton, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K871942 | PERM-CATH CATHETER KIT | Quinton, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K871749 | ADULT PERM-CATH 40CM. | Quinton, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K871487 | VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH | Vas-Cath of Canada , Ltd. | 1987-06-12 | Traditional | PDF ↗ |
| K871488 | VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH | Vas-Cath of Canada , Ltd. | 1987-06-12 | Traditional | PDF ↗ |
| K870328 | SINGLE LUMEN ACUTE CATHETER | Quinton, Inc. | 1987-05-11 | Traditional | PDF ↗ |
| K863697 | MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1986-10-02 | Traditional | PDF ↗ |
| K861174 | SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K860094 | HURWITZ DIALYSIS CATHETER | Gish Biomedical, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K853283 | VACCESS TM 4006 | Vas-Cath of Canada , Ltd. | 1985-08-22 | Traditional | PDF ↗ |
| K852070 | SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL | Shiley, Inc. | 1985-06-13 | Traditional | PDF ↗ |
| K852162 | MNI 400 INJECTION CAPS | Med-West, Inc. | 1985-06-12 | Traditional | PDF ↗ |
| K844336 | VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH | Vas-Cath of Canada , Ltd. | 1985-03-13 | Traditional | PDF ↗ |
| K844433 | VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA | Vas-Cath of Canada , Ltd. | 1985-03-13 | Traditional | PDF ↗ |
| K844434 | VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH | Vas-Cath of Canada , Ltd. | 1985-03-13 | Traditional | PDF ↗ |
| K840197 | SINGLE LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K833848 | DUAL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1983-12-08 | Traditional | PDF ↗ |
| K830438 | MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM | Medcomp | 1983-03-17 | Traditional | PDF ↗ |
| K823135 | DOUBLE LUMEN SUBCLAVIAN CATHETER | Abbott Laboratories | 1983-03-07 | Traditional | PDF ↗ |
| K822964 | RIGHT ATRIAL CATHETER | Quinton, Inc. | 1982-11-30 | Traditional | PDF ↗ |
| K822910 | RIGHT ARTERIAL CATHETER | Quinton, Inc. | 1982-11-29 | Traditional | PDF ↗ |
| K822134 | SHIELY DUEL LUMEN SUBCLAVIAN CANNULA | Shiley, Inc. | 1982-08-03 | Traditional | PDF ↗ |
| K821001 | MCPARLAND SCALP VEIN CATHETER | Renal Systems, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K821955 | MCSCK638 CATHETER IN A TRAY (KIT) | Medcomp | 1982-07-14 | Traditional | PDF ↗ |
| K821954 | MCSCK838 CATHETER IN A TRAY (KIT) | Medcomp | 1982-07-14 | Traditional | PDF ↗ |
| K821684 | MCSCP8PS WITH 'Y' HUB | Medical Components, Inc. | 1982-06-24 | Traditional | PDF ↗ |
| K821400 | MAHURKAR SUBCLAVIAN CATHETER | Quinton, Inc. | 1982-06-23 | Traditional | PDF ↗ |
| K821012 | H-H ALIMENTATION CATHETERS | Holter-Hausner Intl. | 1982-05-28 | Traditional | PDF ↗ |
| K820238 | COBE ACUFLEX SSN, #15-220 | Cobe Laboratories, Inc. | 1982-03-10 | Traditional | PDF ↗ |
| K812326 | SORENSON SUBCLAVIAN CATHETER SSC-8 | Sorensen Research | 1981-09-25 | Traditional | PDF ↗ |
| K810745 | DOUBLE LUMEN SUBCLAVIN CATHETER SC-400 | Vas-Cath of Canada , Ltd. | 1981-03-31 | Traditional | PDF ↗ |
| K801672 | MEDCOMP SUBCLAVIAN CATHETER | Medical Components, Inc. | 1980-12-18 | Traditional | PDF ↗ |
Product code LFJ · Class II · Gastroenterology, Urology. Data: openFDA.