510(k) K201642— Paragon Adult Maxi PMP Oxygenator with Tubing Pack

Substantially Equivalent

Chalice Medical , Ltd.

Clearance details

Applicant: Chalice Medical , Ltd.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2020-06-17
Decision date: 2020-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worksop, GB

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.