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FDA 510(k)

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set

K-Number: K213540 · 2022-05-20

ApplicantQura S.R.L
Decision Date2022-05-20
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set is a medical device manufactured by Qura S.R.L. It received FDA 510(k) clearance on 2022-05-20 under approval number K213540. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set?

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set is a medical device that received FDA 510(k) clearance on 2022-05-20. It is manufactured by Qura S.R.L. The 510(k) number is K213540.

When was Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set approved by the FDA?

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set received FDA 510(k) clearance on 2022-05-20, under approval number K213540.

What company makes Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set?

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set is manufactured by Qura S.R.L.

What is the FDA product code for Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set?

The FDA product code for Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set is DWF.

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Related Devices (Code: DWF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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