DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS— 510(k) K011368

Substantially Equivalent

Gambro Renal Products

FDA 510(k) clearance K011368 for DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS, Substantially Equivalent on 2001-08-02. Applicant: Gambro Renal Products.

Clearance details

Applicant: Gambro Renal Products
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2001-05-04
Decision date: 2001-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daytona Beach, FL, US

Download summary PDF View on FDA.gov ↗

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.