The following data is part of a premarket notification filed by Neuravi Ltd. with the FDA for Embotrap Ii Revascularization Device, Embotrap Iii Revascularization Device.
| Device ID | K212908 |
| 510k Number | K212908 |
| Device Name: | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Neuravi Ltd. Block 3, Ballybrit Business Park Galway, IE H91 K5yd |
| Contact | Niall Fox |
| Correspondent | Niall Fox Neuravi Ltd. Block 3, Ballybrit Business Park Galway, IE H91 K5yd |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-13 |
| Decision Date | 2021-10-13 |