The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Avvigo Guidance System Ii.
| Device ID | K212490 |
| 510k Number | K212490 |
| Device Name: | AVVIGO Guidance System II |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 |
| Contact | Margaret Batchelder |
| Correspondent | Margaret Batchelder Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 |
| Product Code | DQK |
| Subsequent Product Code | DSK |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-10-20 |