COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES— 510(k) K081768
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K081768 for COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES, Substantially Equivalent on 2008-12-23. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code NAJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
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More clearances from Cook Incorporated
view allAdverse events under product code NAJ
product code NAJ- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . 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.