510(k) K240018 ยท DQY Catheter, Percutaneous
WATCHMAN TruSteer Access System (M635TU90050)
| Applicant | Boston Scientific Corporation, Marborough MA, US |
| Decision | Substantially Equivalent, Feb 1, 2024 |
| Received | Jan 2, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K240018
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;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.