FDA device listing
MMT-386T MiniMed Quick-set,MMT-387T MiniMed Quick-set,MMT-394T MiniMed Quick-set,MMT-396T MiniMed Quick-set,MMT-397T…
FDA device listing 2023902106 · Medtronic
Key facts
| Proprietary names | MMT-386T MiniMed Quick-set,MMT-387T MiniMed Quick-set,MMT-394T MiniMed Quick-set,MMT-396T MiniMed Quick-set,MMT-397T MiniMed Quick-set,MMT-398T MiniMed Quick-set,MMT-399T MiniMed Quick-set |
|---|---|
| Owner/operator | Medtronic |
| Owner/operator number | 10094334 |
| Premarket submissions | K011071 |
| Product codes | FPA |
| Device names | FPA - Set, Administration, Intravascular |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| Registered establishments | MEDTRONIC MINIMED |
| Establishment registrations | 2032227 |
| FEI numbers | 3003166194 |
| Establishment operations | Complaint File Establishment |
| 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