FDA device listing
CPB Check Valve
FDA device listing 1093156151 · Terumo Cardiovascular Systems Corp.
Key facts
| Proprietary names | CPB Check Valve |
|---|---|
| Owner/operator | Terumo Cardiovascular Systems Corp. |
| Owner/operator number | 10039199 |
| Premarket submissions | K142500 |
| Product codes | MJJ |
| Device names | MJJ - Cpb Check Valve, Retrograde Flow, In-Line |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4400 |
| Review panels | Cardiovascular |
| Registered establishments | Terumo Cardiovascular Costa Rica LLC |
| Establishment registrations | 3017987980 |
| FEI numbers | 3017987980 |
| Establishment operations | 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