FDA device listing
Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Balance™ Biosurface,Affinity Fusion™ Oxygenator with…
FDA device listing 1916897854 · Medtronic, Inc.
Key facts
| Proprietary names | Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Balance™ Biosurface,Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K240666 |
| Product codes | DTM, DTN, DTZ |
| Device names | DTM - Filter, Blood, Cardiopulmonary Bypass, Arterial Line, DTN - Reservoir, Blood, Cardiopulmonary Bypass, DTZ - Oxygenator, Cardiopulmonary Bypass |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4260, 870.4350, 870.4400 |
| Review panels | Cardiovascular |
| Registered establishments | MEDTRONIC PERFUSION SYSTEMS |
| Establishment registrations | 2184009 |
| FEI numbers | 1000116158 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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