The following data is part of a premarket notification filed by Micro Therapeutics Dba Ev3 Neurovascular with the FDA for Solitaire 2 Revascularization Device.
| Device ID | K123378 |
| 510k Number | K123378 |
| Device Name: | SOLITAIRE 2 REVASCULARIZATION DEVICE |
| Classification | Catheter, Thrombus Retriever |
| Applicant | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Larry Boucher |
| Correspondent | Larry Boucher MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-01 |
| Decision Date | 2012-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536020733 | K123378 | 000 |
| 00847536020726 | K123378 | 000 |
| 00847536020719 | K123378 | 000 |
| 00847536020702 | K123378 | 000 |
| 00836462016408 | K123378 | 000 |
| 00836462016392 | K123378 | 000 |
| 00836462016385 | K123378 | 000 |
| 00836462016378 | K123378 | 000 |