DRYALYSATE CONCENTRATE— 510(k) K980659

Name: FDA 510(k) clearance K980659
Creator: U.S. Food and Drug Administration
Published: 1998-06-11

Substantially Equivalent

Advanced Renal Technologies, Inc.

FDA 510(k) clearance K980659 for DRYALYSATE CONCENTRATE, Substantially Equivalent on 1998-06-11. Applicant: Advanced Renal Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Renal Technologies, Inc.
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1998-02-20
Decision date: 1998-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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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.