VISION HOLLOW FIBER OXYGENATOR WITH HA COATING— 510(k) K080708

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K080708 for VISION HOLLOW FIBER OXYGENATOR WITH HA COATING, Substantially Equivalent on 2009-02-02. Applicant: Gish Biomedical, Inc..

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2008-03-12
Decision date: 2009-02-02
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.