GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER— 510(k) K871108

Name: FDA 510(k) clearance K871108
Creator: U.S. Food and Drug Administration
Published: 1987-05-15

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K871108 for GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER, Substantially Equivalent on 1987-05-15. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 1987-03-19
Decision date: 1987-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

Download summary PDF View on FDA.gov ↗

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K083158 — EXALIS, SOFTWARE VERSION 1.152009-06-05
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K032431 — PRISMA M60/M100 SETS2003-09-15
K896758 — GAMBRO BICARBONATE MONITOR BCM 10-31990-09-28
K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS1990-08-30

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.