HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM— 510(k) K102900

Name: FDA 510(k) clearance K102900
Creator: U.S. Food and Drug Administration
Published: 2012-03-21

Substantially Equivalent

Hei, Inc.

FDA 510(k) clearance K102900 for HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM, Substantially Equivalent on 2012-03-21. Applicant: Hei, Inc.. Device class: 2.

Clearance details

Applicant: Hei, Inc.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2010-09-30
Decision date: 2012-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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 →

Recalls naming K102900

K-number listed on FDA's recall record

Z-2005-2021 — Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.Class I·Terminated·Eight Medical International BV·20210604

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102900.

Data sourced from openFDA. This site is unofficial and independent of the FDA.