K890094

Substantially Equivalent

EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET

Applicant: Kells Medical, Inc.
Product code: KPE
Advisory panel: General Hospital
Date received: 1989-01-10
Decision date: 1989-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, 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.