510(k) K141997— CRIT-LINE IV SYSTEM

Substantially Equivalent

Fresenius Medical Care

Clearance details

Applicant: Fresenius Medical Care
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 2014-07-23
Decision date: 2015-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.