HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM— 510(k) K102900

Substantially Equivalent

Hei, Inc.

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

Clearance details

Applicant: Hei, Inc.
Product code: Code LGZ
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 ↗

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 →

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