FDA device listing
AC3™,AC3 Optimus™,AC3 Series IABP System
FDA device listing 1711696705 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | AC3™,AC3 Optimus™,AC3 Series IABP System |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Premarket submissions | K162820 |
| Product codes | DSP |
| Device names | DSP - System, Balloon, Intra-Aortic And Control |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.3535 |
| Review panels | Cardiovascular |
| Registered establishments | Arrow International LLC (subsidiary of Teleflex Incorporated), Arrow International, LLC (subsidiary of Teleflex Incorporated), Arrow International, LLC (subsidiary of Teleflex, Incorporated) |
| Establishment registrations | 3010532612, 3013162291, 3015859709 |
| FEI numbers | 3010532612, 3013162291, 3015859709 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database