510(k) K212228 ยท DQY Catheter, Percutaneous
WATCHMAN FXD Curve Access System
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 13, 2021 |
| Received | Jul 16, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems. Open, Classified |
DQY | None listed |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of
WATCHMAN FLX LAAC Devices with Delivery Systems. Open, Classified |
DQY | None listed |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems. Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.