MREYE EMBOLIZATION COIL— 510(k) K052834

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K052834 for MREYE EMBOLIZATION COIL, Substantially Equivalent on 2005-11-23. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code KRD
Advisory panel: Cardiovascular
Date received: 2005-10-06
Decision date: 2005-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

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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.