Name: Predicase
Price: 199 USD

K-number	K241352
Device name	Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
Applicant	Medtronic, Inc.
Product code	DTZ
Device class	Class II
Decision date	Jun 12, 2024
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

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