Quadrox-I Microporporous Membrane Oxgenator Series And Qudrox-Id Diffusion Memb…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112360 FDA 510(k)
- FDA Product Code
- DTZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4350 FDA 510(k)
- Regulation Number
- 870.4350 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quadrox-I Microporous Membrane Oxygenator Series and Quadrox-ID Diffusion Membrane Oxygenator Series are extracorporeal blood oxygenators designed for use in cardiopulmonary bypass during cardiac surgery. These devices facilitate gas exchange by oxygenating blood and removing carbon dioxide, while also enabling temperature regulation within specified flow rates. The microporous membrane technology minimizes blood contact with foreign surfaces, enhancing biocompatibility and safety during perfusion procedures.
These devices are supplied as single-use, sterile products and are classified as Class II medical devices under FDA regulations. They are intended for use in controlled clinical settings such as operating rooms and cardiac catheterization labs. The Quadrox-I series includes models tailored for small adult and adult patients, with modular designs to accommodate varying perfusion requirements. Authorized under FDA 510(k) clearance (K112360), these oxygenators comply with regulatory standards for extracorporeal circulation devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Quadrox-i Microporporous Membrane Oxgenator Series and Qudrox-id ..., PDF QUADROX-i Small Adult and Adult Choose maximum safety., MAQUET QuadroX-i Oxygenator Overview | PDF | Hemodynamics | Blood - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112360 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
- FDA Applicant
- Maquet Cardiopulmonary, AG
Sources (1)
- FDA 510(k) K112360 24 fields · synced Oct 6, 2026