K260816
- 510(k) number
- K260816
- Device name
- OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)
- Applicant
- Boston Scientific MN · US
- Product code
- OBJ — Catheter, Ultrasound, Intravascular
- Decision date
- 2026-04-08
- Date received
- 2026-03-13
- 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: K260816.pdf
Official FDA record: K260816
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.