FDA device listing
Prestige Coil System,Prestige Plus Coil System
FDA device listing 1280004328 · Balt USA, LLC
Key facts
| Proprietary names | Prestige Coil System,Prestige Plus Coil System |
|---|---|
| Owner/operator | Balt USA, LLC |
| Owner/operator number | 10041614 |
| Premarket submissions | K220699 |
| Product codes | KRD |
| Device names | KRD - Device, Vascular, For Promoting Embolization |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.3300 |
| Review panels | Cardiovascular |
| Registered establishments | BALT USA, LLC |
| Establishment registrations | 3014162263 |
| FEI numbers | 3014162263 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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