K240018
- 510(k) number
- K240018
- Device name
- WATCHMAN TruSteer Access System (M635TU90050)
- Applicant
- Boston Scientific Corporation MA · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2024-02-01
- Date received
- 2024-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240018.pdf
Official FDA record: K240018
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.