Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home— 510(k) K143016

Substantially Equivalent

Cardinalhealth

FDA 510(k) clearance K143016 for Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home, Substantially Equivalent on 2015-04-20. Applicant: Cardinalhealth.

Clearance details

Applicant: Cardinalhealth
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2014-10-20
Decision date: 2015-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

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Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.