510(k) K180864 ยท DQY Catheter, Percutaneous
WATCHMAN TruSeal Access System
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jul 20, 2018 |
| Received | Apr 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys Open, Classified |
DQY | None listed |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys Open, Classified |
DQY | None listed |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys Open, Classified |
DQY | None listed |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Syst Open, Classified |
DQY | None listed |
| Aug 29, 2025 | Boston Scientific Corporation WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Syst Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.