MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT— 510(k) K090450

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K090450 for MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT, Substantially Equivalent on 2009-09-18. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2009-02-20
Decision date: 2009-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa Margarita, CA, 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.