Arrow International, LLC · Class II · Cleared Mar 26, 2025
| K-number | K250542 |
| Device name | AC3 Range Intra-Aortic Balloon Pump |
| Applicant | Arrow International, LLC |
| Product code | DSP |
| Device class | Class II |
| Decision date | Mar 26, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.3535 |
The AC3 Range Intra-Aortic Balloon Pump (IABP) is a counter-pulsation therapy device for adult patients with impaired left ventricular function. It provides hemodynamic support by reducing cardiac workload and improving blood pressure through volume displacement. The device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The AC3 Range IABP is a compact version of the AC3 Optimus IABP with a low profile design for improved transportability in air and ground transport modes (helicopter, plane, ambulance). It consists of a pump control/display module with high-definition touchscreen and keypad, plus a pneumatic drive module with wheels. The system operates in two modes: AutoPilot (automatic) and Operator (manual control).
Not stated in this summary.
The AC3 Range IABP demonstrates substantial equivalence through identical indications for use, fundamental technologies, and principles of operation compared to the predicate device (K232343—AC3 Series IAB Pump). Mechanical and General Safety Testing confirmed equivalent performance with no new safety or effectiveness concerns raised by the technological differences.
View the full FDA submission: accessdata.fda.gov