K241768

Substantially Equivalent

Broadway 8 Catheter

Applicant
Stryker Neurovascular
Product code
QJP
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fremont, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code QJP

product code QJP
Death
43
Injury
233
Malfunction
1,010
Total
1,286

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.