LDFClass II
Electrode, Pacemaker, Temporary
21 CFR 870.3680 / Cardiovascular
LDF is the FDA product code for Electrode, Pacemaker, Temporary, a class II device type, regulated under 21 CFR 870.3680. As of , FDA records hold 130 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- LDF
- Device name
- Electrode, Pacemaker, Temporary
- Regulation
- 21 CFR 870.3680
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 130
- Ingested recalls
- 15
Clearances, product code LDF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 14 |
| 1982 | 8 |
| 1983 | 7 |
| 1984 | 5 |
| 1985 | 9 |
| 1986 | 3 |
| 1987 | 7 |
| 1988 | 4 |
| 1989 | 4 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 5 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 6 |
| 1996 | 5 |
| 1997 | 6 |
| 1998 | 2 |
| 2000 | 2 |
| 2001 | 8 |
| 2003 | 3 |
| 2004 | 3 |
| 2008 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| 2025 | 5 |
| 2026 | 1 |
Applicants with the most clearances
Product code LDF| Applicant | Clearances |
|---|---|
| Medtronic, Inc. | 26 |
| C.R. Bard Inc | 8 |
| Electro-Catheter Corp. | 7 |
| Cordis US Corp. | 5 |
| Ethicon, Inc | 5 |
| Oscor Medical Corp. | 4 |
| Oscor Inc. | 4 |
| Daig Corp. | 3 |
| Numed Inc | 3 |
| Abbott Medical | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.