DSP
- Product code
- DSP
- Device name
- System, Balloon, Intra-Aortic And Control
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.3535
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 162 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250542 | 2025-03-26 | Arrow International, LLC | AC3 Range Intra-Aortic Balloon Pump |
Official FDA classification page: DSP
Classification and pathway per current FDA publications. Data from openFDA (CC0).