K200733

Substantially Equivalent

Opticross 35 15 MHz Peripheral Imaging Catheter

Applicant: Boston Scientific Corporation
Product code: ITX
Advisory panel: Radiology
Date received: 2020-03-20
Decision date: 2020-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.