OXYGENATOR, BLOOD BOS-10— 510(k) K781842

Substantially Equivalent

Bentley Laboratories, Inc.

FDA 510(k) clearance K781842 for OXYGENATOR, BLOOD BOS-10, Substantially Equivalent on 1978-11-08. Applicant: Bentley Laboratories, Inc..

Clearance details

Applicant: Bentley Laboratories, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1978-10-27
Decision date: 1978-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.