J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO— 510(k) K853251

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K853251 for J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO, Substantially Equivalent on 1985-10-16. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1985-07-29
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, 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.