FDA device listing
Solitaire X Revascularization Device
FDA device listing 1556161200 · Medtronic, Inc.
Key facts
| Proprietary names | Solitaire X Revascularization Device |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K203358 |
| Product codes | NRY, POL |
| Device names | NRY - Catheter, Thrombus Retriever, POL - Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1250, 882.5600 |
| Review panels | Cardiovascular, Neurology |
| Registered establishments | Medtronic Distribution Center, MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR |
| Establishment registrations | 2029214, 3009380063, 3015550451 |
| FEI numbers | 1000220862, 3009380063, 3015550451 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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