Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K123378
SOLITAIRE 2 REVASCULARIZATION DEVICE · Micro Therapeutics Dba Ev3 Neurovascular · decided 2012-11-30 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Solitaire 2 | SFR2-6-20 | Micro Therapeutics, Inc. | NRY POL | 00836462016392 |
| SolitiareTM | SFR2-4-15 | Micro Therapeutics, Inc. | NRY POL | 00847536020702 |
| SolitiareTM | SFR2-4-20 | Micro Therapeutics, Inc. | NRY POL | 00847536020719 |
| SolitiareTM | SFR2-6-20 | Micro Therapeutics, Inc. | NRY POL | 00847536020726 |
| Solitaire 2 | SFR2-4-20 | Micro Therapeutics, Inc. | NRY POL | 00836462016385 |
| SolitiareTM | SFR2-6-30 | Micro Therapeutics, Inc. | NRY POL | 00847536020733 |
| Solitaire 2 | SFR2-4-15 | Micro Therapeutics, Inc. | NRY | 00836462016378 |
| Solitaire 2 | SFR2-6-30 | Micro Therapeutics, Inc. | NRY POL | 00836462016408 |