K192398

Substantially Equivalent

Millenium HX

Applicant: Mar Cor Purification, Inc.
Product code: FIP
Advisory panel: Gastroenterology, Urology
Date received: 2019-09-03
Decision date: 2019-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

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.