LFJClass II
Catheter, Subclavian
21 CFR 876.5540 / Gastroenterology, Urology
LFJ is the FDA product code for Catheter, Subclavian, a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 65 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- LFJ
- Device name
- Catheter, Subclavian
- Regulation
- 21 CFR 876.5540
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 65
- Ingested recalls
- 6
Clearances, product code LFJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 10 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 6 |
| 1986 | 3 |
| 1987 | 5 |
| 1988 | 8 |
| 1989 | 6 |
| 1990 | 9 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 6 |
Applicants with the most clearances
Product code LFJ| Applicant | Clearances |
|---|---|
| Akcess Medical Products, Inc. | 12 |
| Quinton, Inc. | 8 |
| Vas-Cath of Canada, Ltd. | 8 |
| Shiley, Inc. | 7 |
| Medical Components, Inc. | 5 |
| Vas-Cath, Inc. | 5 |
| Medcomp | 3 |
| Impra, Inc. | 2 |
| Medsurg Industries, Inc. | 2 |
| Abbott Medical | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Arrow Internacional de Chihuahua S.A. de C.V.
- Arrow International C.R. A.S.
- Bard Access Systems, Inc.
- Bard Reynosa S.A. de C.V.
- Isomedix Operations Inc
- Martech Medical Products
- Martech Medical Products S. de RL. de CV.
- Medical Components, Inc.
- Medron, LLC
- Medtronic, Inc.
- Mozarc Medical US LLC
- Paragon Medical - Mansfield, Bridgemedica
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
