Century Perfusion System— 510(k) K202125

Substantially Equivalent

Century Hlm, LLC

FDA 510(k) clearance K202125 for Century Perfusion System, Substantially Equivalent on 2021-03-07. Applicant: Century Hlm, LLC.

Clearance details

Applicant: Century Hlm, LLC
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2020-07-31
Decision date: 2021-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mesa, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.