LFJ — Catheter, Subclavian Class II
FDA product code LFJ covers "Catheter, Subclavian", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LFJ
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K920780 | medsurg industries | MEDSURG INSERTION TRAY | August 19, 1994 |
| K925819 | akcess medical products | AKCESS0CATH KIT | August 2, 1994 |
| K925818 | akcess medical products | AKCESS-CATH | April 5, 1994 |
| K913468 | cook | ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY | March 24, 1994 |
| K920634 | akcess medical products | SPLITTABLE SHEATH INTRODUCER SET | January 14, 1994 |
| K931120 | akcess medical products | COAXIAL ACUTE CATHETER | January 14, 1994 |
| K914162 | vas-cath | VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS | July 1, 1993 |
| K915423 | medical components | HEMO-CATH SILICONE ACCESS CATHETER | February 2, 1993 |
| K914826 | akcess medical products | AKCESS-CATH KIT | April 10, 1992 |
| K910501 | akcess medical products | PERMANENT SILICONE CATHETERS | April 29, 1991 |
| K905080 | kendall healthcare products co. div.of tyco health | MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER | January 31, 1991 |
| K904139 | akcess medical products | SINGLE LUMEN CATHETER KITS | December 4, 1990 |
| K904140 | akcess medical products | SINGLE LUMEN CATHETERS, MODIFICATION | November 27, 1990 |
| K901133 | impra | DURACATH | June 8, 1990 |
| K901061 | akcess medical products | SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000 | May 22, 1990 |
| K896568 | vygon | DUALYSE-CATH - CODES #1132.212, 1132.112 | May 9, 1990 |
| K900835 | quinton | MODIFIED PERM-CATH | May 9, 1990 |
| K900803 | akcess medical products | DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S | April 25, 1990 |
| K895506 | vas-cath | FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER | February 9, 1990 |
| K895417 | arrow intl | ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT | January 3, 1990 |