MVR Venous Reservoir Bag 800 mL +3 more— 510(k) K241053

Name: FDA 510(k) clearance K241053
Creator: U.S. Food and Drug Administration
Published: 2024-05-15

Substantially Equivalent

Medtronic Cardiac Surgery

FDA 510(k) clearance K241053 for MVR Venous Reservoir Bag 800 mL +3 more, Substantially Equivalent on 2024-05-15. Applicant: Medtronic Cardiac Surgery. Device class: 2.

Clearance details

Device name as filed: MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL
Applicant: Medtronic Cardiac Surgery
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 2024-04-17
Decision date: 2024-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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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.