LDF
- Product code
- LDF
- Device name
- Electrode, Pacemaker, Temporary
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.3680
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 130 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252042 | 2026-07-30 | Swift Sync, Inc. | Sync AV II Temporary Pacing Catheter | |
| K242863 | 2025-06-15 | Bioptimal International Pte. , Ltd. | Bioptimal Bipolar Pacing Catheter | |
| K251186 | 2025-05-15 | C.R. Bard, Inc. | Bard® Temporary Pacing Electrode Catheter Needle / | |
| K241334 | 2025-01-31 | C.R. Bard, Inc. | Semi-Floating Temporary Pacing Electrode Catheter, B | |
| K241199 | 2025-01-23 | Shenzhen Launch Electrical Co., Ltd. | Rotatable Connector (5944RL) | |
| K242705 | 2025-01-17 | Medtronic, Inc. | Streamline Unipolar Pediatric Temporary Pacing Lead | |
| K232261 | 2024-04-26 | Osypka AG | TME Temporary Myocardial Electrode | FDA |
Official FDA classification page: LDF
Classification and pathway per current FDA publications. Data from openFDA (CC0).