FDA device listing
D731 MICRO 27 Ph.I.S.I.O.,D733 MICRO 40 Ph.I.S.I.O.
FDA device listing 1789969831 · SORIN GROUP ITALIA S.R.L
Key facts
| Proprietary names | D731 MICRO 27 Ph.I.S.I.O.,D733 MICRO 40 Ph.I.S.I.O. |
|---|---|
| Owner/operator | SORIN GROUP ITALIA S.R.L |
| Owner/operator number | 9011842 |
| Premarket submissions | K112525 |
| Product codes | DTM |
| Device names | DTM - Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4260 |
| Review panels | Cardiovascular |
| Registered establishments | SORIN GROUP ITALIA S.R.L |
| Establishment registrations | 9680841 |
| FEI numbers | 3005426550 |
| 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