CES VASCULAR OCCLUSION SYSTEM— 510(k) K972881

Substantially Equivalent

Cordis Neurovascular, Inc.

FDA 510(k) clearance K972881 for CES VASCULAR OCCLUSION SYSTEM, Substantially Equivalent on 1998-06-04. Applicant: Cordis Neurovascular, Inc..

Clearance details

Applicant: Cordis Neurovascular, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 1997-08-05
Decision date: 1998-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lake, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.