K162887

Substantially Equivalent

PrismaSATE

Applicant: Baxter Healthcare Corporation
Product code: KPO
Advisory panel: Gastroenterology, Urology
Date received: 2016-10-17
Decision date: 2017-01-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Lake, IL, US

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.