K-number	K213540
Device name	Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
Applicant	Qura S.R.L
Product code	DWF
Device class	Class II
Decision date	May 20, 2022
Decision	Substantially Equivalent
Regulation	870.4210

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Source

View the full FDA submission: accessdata.fda.gov

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Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set

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