K822803

Substantially Equivalent

BLOOD OXYGENATORS #BOS-105S BOS-5S W/

Applicant: Bentley Laboratories, Inc.
Product code: DTZ
Advisory panel: Cardiovascular
Date received: 1982-09-17
Decision date: 1982-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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.