K121161

Substantially Equivalent

EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER

Applicant: Acta Medical, LLC
Product code: KPE
Advisory panel: General Hospital
Date received: 2012-04-17
Decision date: 2012-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.