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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 the device name listed in this FDA 510(k) record. The listed applicant is Qura S.R.L. It received FDA 510(k) clearance on 2022-05-20 under 510(k) 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. The listed applicant is Qura S.R.L. The 510(k) number is K213540.

When did Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set?

The FDA 510(k) record lists Qura S.R.L as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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