K262165
- 510(k) number
- K262165
- Device name
- FARADRIVE Steerable Sheath (M004PF21M402)
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DRA — Catheter, Steerable
- Decision date
- 2026-07-24
- Date received
- 2026-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K262165.pdf
Official FDA record: K262165
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.