WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR— 510(k) K872107

Substantially Equivalent

Minntech Corp.

FDA 510(k) clearance K872107 for WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR, Substantially Equivalent on 1987-08-28. Applicant: Minntech Corp..

Clearance details

Applicant: Minntech Corp.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1987-06-09
Decision date: 1987-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.