Name: Predicase
Price: 199 USD

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
Product code	DTN
Device class	Class II
Decision date	May 15, 2024
Decision	Substantially Equivalent
Regulation	870.4400

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Source

View the full FDA submission: accessdata.fda.gov

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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

Everything you need for a 510(k) submission. Nothing you don't.

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