U9000 Plus Ultrafilter— 510(k) K211035

Substantially Equivalent

Baxter Healthcare Corporation

FDA 510(k) clearance K211035 for U9000 Plus Ultrafilter, Substantially Equivalent on 2021-10-19. Applicant: Baxter Healthcare Corporation.

Clearance details

Applicant: Baxter Healthcare Corporation
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2021-04-07
Decision date: 2021-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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.