DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Century Hlm, LLC
Product code
Code DTQ
Device class
Class 2
Regulation
21 CFR 870.4220
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mesa, AZ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DTQ

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Adverse events under product code DTQ

product code DTQ
Death
123
Malfunction
4,822
Other
1
Total
4,946

Source: openFDA MAUDE database, through . 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.