The following data is part of a premarket notification filed by Neuravi Ltd. with the FDA for Embotrap Ll Revascularization Device.
| Device ID | K173452 |
| 510k Number | K173452 |
| Device Name: | EmboTrap Ll Revascularization Device |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Neuravi Ltd. Block 3, Ballybrit Business Park Galway, IE |
| Contact | Mairsil Claffey |
| Correspondent | Mairsil Claffey Neuravi Ltd. Block 3, Ballybrit Business Park Galway, IE |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-06 |
| Decision Date | 2018-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704081326 | K173452 | 000 |
| 10886704081319 | K173452 | 000 |