K233248
- 510(k) number
- K233248
- Device name
- FARADRIVE Steerable Sheath
- Applicant
- Boston Scientific Corporation MN · US
- Product code
- DRA — Catheter, Steerable
- Decision date
- 2023-12-11
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233248.pdf
Official FDA record: K233248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.