The following data is part of a premarket notification filed by Micro Therapeutics Dba Ev3 Neurovascular with the FDA for Solitaire Fr Revascularization Device.
| Device ID | K113455 |
| 510k Number | K113455 |
| Device Name: | SOLITAIRE FR REVASCULARIZATION DEVICE |
| Classification | Catheter, Thrombus Retriever |
| Applicant | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Laura Heaton |
| Correspondent | Laura Heaton MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462016163 | K113455 | 000 |
| 00836462016156 | K113455 | 000 |
| 00836462016149 | K113455 | 000 |
| 00836462016132 | K113455 | 000 |