Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K113455
SOLITAIRE FR REVASCULARIZATION DEVICE · Micro Therapeutics Dba Ev3 Neurovascular · decided 2012-03-02 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Solitaire FR | SFR-4-15 | Micro Therapeutics, Inc. | NRY | 00836462016132 |
| Solitaire FR | SFR-6-20 | Micro Therapeutics, Inc. | NRY | 00836462016156 |
| Solitaire FR | SFR-6-30 | Micro Therapeutics, Inc. | NRY | 00836462016163 |
| Solitaire FR | SFR-4-20 | Micro Therapeutics, Inc. | NRY | 00836462016149 |