FDA device listing
Arterial Access Tray,Arterial Catheterization Kit,Arterial Catheter Kit,Arterial Cath Kit,Arterial Line Kit,Art./Venous…
FDA device listing 1649536707 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | Arterial Access Tray,Arterial Catheterization Kit,Arterial Catheter Kit,Arterial Cath Kit,Arterial Line Kit,Art./Venous Cath Set,CVC Kit,Micro Introducer Set,RA Cath Kit,Radial Artery Catheter,Spring Wire Guide Component |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Product codes | OFB |
| Device names | OFB - Catheter Guide Wire Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1330 |
| Review panels | Cardiovascular |
| Registered establishments | Arrow Internacional de Chihuahua S.A. de C.V., Arrow International, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 3015859709 |
| FEI numbers | 3003737899, 3015859709 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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