DeviceClearance

K173820

Substantially Equivalent

OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)

Applicant
Boston Scientific Corporation
Product code
OBJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Fremont, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OBJ

product code OBJ
Death
38
Injury
634
Malfunction
3,453
Total
4,125

Source: openFDA MAUDE database, through . 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.