The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Watchman Fxd Curve Access System.
| Device ID | K212228 |
| 510k Number | K212228 |
| Device Name: | WATCHMAN FXD Curve Access System |
| Classification | Catheter, Percutaneous |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Alexa M. Keenan |
| Correspondent | Alexa M. Keenan Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-16 |
| Decision Date | 2021-08-13 |