FDA device listing
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR
FDA device listing 2070184441 · TERUMO MEDICAL CORP.
Key facts
| Proprietary names | CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR |
|---|---|
| Owner/operator | TERUMO MEDICAL CORP. |
| Owner/operator number | 9003933 |
| Premarket submissions | K961000 |
| Product codes | DTZ |
| Device names | DTZ - Oxygenator, Cardiopulmonary Bypass |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4350 |
| Review panels | Cardiovascular |
| Registered establishments | Terumo Medical Canada, Inc. |
| Establishment registrations | 3008307705 |
| FEI numbers | 3008307705 |
| Establishment operations | Foreign Exporter |
| 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