HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131— 510(k) K091703

Substantially Equivalent

Concentric Medical, Inc.

FDA 510(k) clearance K091703 for HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131, Substantially Equivalent on 2009-10-14. Applicant: Concentric Medical, Inc..

Clearance details

Applicant: Concentric Medical, Inc.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.