DeviceClearance

Product code DTZ— Cardiovascular

WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR

Classification name
Oxygenator, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4350
Advisory panel
Cardiovascular
Total cleared
254
First cleared
Most recent

Market context for product code DTZ

FDA has cleared 254 devices under product code DTZ between 1976 and 2026, filed by 62 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code DTZ

Adverse events under product code DTZ

product code DTZ
Death
182
Injury
422
Malfunction
3,636
Total
4,240

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DTZ

1–100 of 254

Data sourced from openFDA. This site is unofficial and independent of the FDA.