Name: Predicase
Price: 199 USD

K-number	K220110
Device name	Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
Applicant	Qura S.R.L
Product code	DTR
Device class	Class II
Decision date	May 6, 2022
Decision	Substantially Equivalent
Regulation	870.4240

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger

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