Skip to content

Quantum Perfusion Blood Oxygenator VT75-E1, VT75-E2

by Qura S.R.L 510(k)

Active United States

510(k) K231982

Overview

The Quantum Perfusion Blood Oxygenator VT75-E1 and VT75-E2 are oxygenators used in cardiopulmonary bypass procedures. They are classified as class 2 devices and are regulated under regulation number 870.4350. The devices are used in the medical specialty of cardiovascular care. As oxygenators, they are designed to oxygenate blood during cardiopulmonary bypass procedures.

The Quantum Perfusion Blood Oxygenators are supplied in two models, VT75-E1 and VT75-E2. The devices have been cleared by the FDA with a 510(k) number of K231982 and are classified as substantially equivalent. They are intended for use in a clinical setting and are subject to the regulations and guidelines set forth by the FDA. The devices are stored and used in accordance with the manufacturer's instructions and are subject to the applicable storage and handling procedures.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231982 Date12 Sep 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
510(k) Number
FDA Product Code
DTZ
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Qura S.R.L

See all devices from Qura S.R.L →

Questions

  • What is the Quantum Perfusion Blood Oxygenator used for?

    The Quantum Perfusion Blood Oxygenator is used in cardiopulmonary bypass procedures to oxygenate blood, and is intended for use in a clinical setting.

  • How are the Quantum Perfusion Blood Oxygenators supplied?

    The Quantum Perfusion Blood Oxygenators are supplied in two models, VT75-E1 and VT75-E2, and are subject to the manufacturer's instructions for storage and handling.

  • Are the Quantum Perfusion Blood Oxygenators cleared by the FDA?

    Yes, the Quantum Perfusion Blood Oxygenators have been cleared by the FDA with a 510(k) number of K231982 and are classified as substantially equivalent.

  • What medical specialty are the Quantum Perfusion Blood Oxygenators used in?

    The Quantum Perfusion Blood Oxygenators are used in the medical specialty of cardiovascular care.