DWA
- Product code
- DWA
- Device name
- Control, Pump Speed, Cardiopulmonary Bypass
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4380
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 37 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232788 | 2024-05-24 | Inspira Technologies Oxy B.H.N. , Ltd. | INSPIRA ART100 |
Official FDA classification page: DWA
Classification and pathway per current FDA publications. Data from openFDA (CC0).