FDA device listing
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
FDA device listing 1589503568 · C. R. Bard, Inc.
Key facts
| Proprietary names | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Premarket submissions | K242429 |
| Product codes | SEF |
| Device names | SEF - Central Venous Catheter With Manual Insertion System |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5200 |
| Review panels | General Hospital |
| Registered establishments | Bard Access Systems, Inc., BARD REYNOSA S.A. DE C.V. |
| Establishment registrations | 9617592, 3006260740 |
| FEI numbers | 3002468371, 3006260740 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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