MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG— 510(k) K911106

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K911106 for MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG, Substantially Equivalent on 1991-05-28. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1991-03-12
Decision date: 1991-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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.