OptiCross Coronary Imaging Catheter (H749518110) +7 more— 510(k) K260816

Name: FDA 510(k) clearance K260816
Creator: U.S. Food and Drug Administration
Published: 2026-04-08

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K260816 for OptiCross Coronary Imaging Catheter (H749518110) +7 more, Substantially Equivalent on 2026-04-08. Applicant: Boston Scientific. Device class: 2.

Summary

Boston Scientific's record names eight OptiCross Coronary Imaging Catheter entries: the OptiCross, OptiCross 6, OptiCross HD, and OptiCross 6 HD, each also listed in a Bagless version, with a separate number for each. All are filed under product code OBJ (Catheter, Ultrasound, Intravascular).

Class II, 21 CFR 870.1200. It came in as a Special 510(k), and Cardiovascular is both the classification panel and the review panel.

Boston Scientific filed from Maple Grove, Minnesota. Review took 26 calendar days (March 13 to April 8, 2026).

Clearance details

Device name as filed: 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
Product code: Product code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2026-03-13
Decision date: 2026-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.