K091703

Substantially Equivalent

HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131

Applicant: Concentric Medical, Inc.
Product code: QEZ
Advisory panel: Cardiovascular
Date received: 2009-06-10
Decision date: 2009-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.