WATCHMAN TruSeal Access System
FDA 510(k) clearance K180864 · decided 2018-07-20
Clearance details
- K-number
- K180864
- Device name
- WATCHMAN TruSeal Access System
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2018-04-02
- Decision date
- 2018-07-20
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to pr recall (Z-2426-2025) | Boston Scientific Corporation | 2025-08-29 |
| WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to pr recall (Z-2427-2025) | Boston Scientific Corporation | 2025-08-29 |
| WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to pr recall (Z-2428-2025) | Boston Scientific Corporation | 2025-08-29 |
| WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to pro recall (Z-2431-2025) | Boston Scientific Corporation | 2025-08-29 |
| WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to pro recall (Z-2432-2025) | Boston Scientific Corporation | 2025-08-29 |