MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT— 510(k) K082403

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K082403 for MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT, Substantially Equivalent on 2009-05-15. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2008-08-21
Decision date: 2009-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.