LDR
- Product code
- LDR
- Device name
- Controller, Infusion, Intravascular, Electronic
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 60 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242693 | 2024-10-07 | Deka Research and Development Corporat… | DEKA Infusion System, DEKA Administration Set | |
| K232316 | 2024-03-01 | Deka Research and Development | DEKA Infusion System, DEKA Administration Set |
Official FDA classification page: LDR
Classification and pathway per current FDA publications. Data from openFDA (CC0).