COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES— 510(k) K081768

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K081768 for COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES, Substantially Equivalent on 2008-12-23. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code NAJ
Advisory panel: Cardiovascular
Date received: 2008-06-20
Decision date: 2008-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NAJ

product code NAJ

Death: 3
Total: 3

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.