K093002

Substantially Equivalent

AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610

Applicant: MicroVention, Inc.
Product code: KRD
Advisory panel: Cardiovascular
Date received: 2009-09-28
Decision date: 2009-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Tistin, CA, US

Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

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.