DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD— 510(k) K910107

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K910107 for DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD, Substantially Equivalent on 1991-04-10. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1991-01-10
Decision date: 1991-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.