Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K153071
Solitaire Platinum Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · decided 2015-12-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SolitaireTM | SFR3-4-20-10 | Micro Therapeutics, Inc. | NRY POL | 00847536020528 |
| SolitaireTM | SFR3-4-40-10 | Micro Therapeutics, Inc. | NRY | 00847536020535 |
| Solitaire™ | SFR3-4-40-10 | Micro Therapeutics, Inc. | NRY POL | 00847536033948 |
| SolitaireTM | SFR3-6-20-10 | Micro Therapeutics, Inc. | NRY POL | 00847536020542 |
| Solitaire™ | SFR3-4-20-10 | Micro Therapeutics, Inc. | NRY | 00847536033931 |
| Solitaire™ | SFR3-6-20-10 | Micro Therapeutics, Inc. | NRY | 00847536033955 |