TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT— 510(k) K122576

Substantially Equivalent

Stryker Neurovascular

FDA 510(k) clearance K122576 for TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT, Substantially Equivalent on 2013-01-11. Applicant: Stryker Neurovascular.

Clearance details

Applicant: Stryker Neurovascular
Product code: 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

Download summary PDF View on FDA.gov ↗

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.