The following data is part of a premarket notification filed by Neuravi Limited with the FDA for Emboguard Balloon Guide Catheter.
| Device ID | K212340 |
| 510k Number | K212340 |
| Device Name: | EMBOGUARD Balloon Guide Catheter |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Neuravi Limited Block 3, Ballybrit Business Park Galway, IE H91 K5yd |
| Contact | Niall Fox |
| Correspondent | Niall Fox Neuravi Limited Block 3, Ballybrit Business Park Galway, IE H91 K5yd |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-28 |
| Decision Date | 2021-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704082743 | K212340 | 000 |
| 10886704082736 | K212340 | 000 |