Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)— 510(k) K191246

Substantially Equivalent

Chalice Medical , Ltd.

FDA 510(k) clearance K191246 for Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP), Substantially Equivalent on 2020-02-28. Applicant: Chalice Medical , Ltd..

Clearance details

Applicant: Chalice Medical , Ltd.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2019-05-09
Decision date: 2020-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worksop, GB

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.