K241053

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

510(k) number: K241053
Device name: 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 MN · US
Product code: DTN — Reservoir, Blood, Cardiopulmonary Bypass
Decision date: 2024-05-15
Date received: 2024-04-17
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K241053.pdf

Official FDA record: K241053

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.