TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT— 510(k) K021287

Substantially Equivalent

Medtronic Perfusion Systems

FDA 510(k) clearance K021287 for TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT, Substantially Equivalent on 2002-05-07. Applicant: Medtronic Perfusion Systems.

Clearance details

Applicant: Medtronic Perfusion Systems
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2002-04-23
Decision date: 2002-05-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.