THB 6000 HARDSHELL BUBBLE OXYGENATOR— 510(k) K803231

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K803231 for THB 6000 HARDSHELL BUBBLE OXYGENATOR, Substantially Equivalent on 1981-01-16. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1980-12-22
Decision date: 1981-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.