FDA device listing
AutoCAT®2 Intra-Aortic Balloon Pump (IABP),AutoCAT®2 Series,AutoCAT®2WAVE Intra-Aortic Balloon Pump (IABP),Fiber Optic…
FDA device listing 2016978225 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | AutoCAT®2 Intra-Aortic Balloon Pump (IABP),AutoCAT®2 Series,AutoCAT®2WAVE Intra-Aortic Balloon Pump (IABP),Fiber Optic System (FOS),FIBEROPTIX®,FiberOptix® IAB Catheter,,Intra-Aortic Balloon Catheter, Ultra 8®,Intra-Aortic Balloon (IAB) Catheter,RediGuard® Intra-Aortic Balloon Catheter |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Premarket submissions | K021462 |
| 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 Internacional de Chihuahua S.A. de C.V., Arrow International LLC (subsidiary of Teleflex Incorporated), Arrow International, LLC (subsidiary of Teleflex, Incorporated) |
| Establishment registrations | 9680794, 3010532612, 3013162291 |
| FEI numbers | 3003737899, 3010532612, 3013162291 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer |
| 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