K122576

Substantially Equivalent

TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT

Applicant: Stryker Neurovascular
Product code: MJN
Advisory panel: Cardiovascular
Date received: 2012-08-23
Decision date: 2013-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.