The following data is part of a premarket notification filed by Neuravi, Ltd. with the FDA for Embotrap Iii Revascularization Device.
| Device ID | K193063 |
| 510k Number | K193063 |
| Device Name: | 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-04 |
| Decision Date | 2020-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704084570 | K193063 | 000 |
| 10886704082866 | K193063 | 000 |