K101354

Substantially Equivalent

FETCH 2 ASPIRATION CATHETER MODEL 109400-001

Applicant: Medrad Interventional/Possis
Product code: QEZ
Advisory panel: Cardiovascular
Date received: 2010-05-14
Decision date: 2011-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.