ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS— 510(k) K010760

Substantially Equivalent

Advanced Renal Technologies, Inc.

FDA 510(k) clearance K010760 for ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS, Substantially Equivalent on 2001-06-11. Applicant: Advanced Renal Technologies, Inc..

Clearance details

Applicant: Advanced Renal Technologies, Inc.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2001-03-13
Decision date: 2001-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

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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.