Quadrox-I Adult Microporous Membrane Oxygenator With Bioline Coating, Model BEHMO70000, BEQ-HMO70000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090511 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 Adult Microporous Membrane Oxygenator is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter, intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It features a microporous membrane with Bioline coating and is designed for blood flow rates from 0.5 to 7 l/min.
The device is supplied as a single-use product and is classified as a Class II oxygenator for cardiopulmonary bypass. It has received FDA 510(k) clearance with the K090511 number and is manufactured by Maquet Cardiopulmonary AG in Hirrlingen, Germany. The device is authorized for use in cardiovascular procedures and is regulated under product code DTZ.
Frequently asked questions
What is the Quadrox-I Adult Oxygenator used for?
The Quadrox-I Adult Microporous Membrane Oxygenator is a blood-gas exchanger with integrated heat exchanger, intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It features a microporous membrane with Bioline coating and is designed for blood flow rates from 0.5 to 7 l/min.
Is the Quadrox-I Adult Oxygenator supplied as a single-use product?
Yes, the Quadrox-I Adult Microporous Membrane Oxygenator is supplied as a single-use product and is classified as a Class II oxygenator for cardiopulmonary bypass. It is not designed for reuse and should be discarded after a single procedure.
What regulatory approvals does the Quadrox-I Adult Oxygenator have?
The device has received FDA 510(k) clearance with the K090511 number and is manufactured by Maquet Cardiopulmonary AG in Hirrlingen, Germany. It is authorized for use in cardiovascular procedures and is regulated under product code DTZ.
What are the specifications of the Quadrox-I Adult Oxygenator?
The Quadrox-I Adult Microporous Membrane Oxygenator is designed for blood flow rates from 0.5 to 7 l/min. It features a microporous membrane with Bioline coating and may include an integrated arterial blood filter option. The device is manufactured by Maquet Cardiopulmonary AG in Hirrlingen, Germany.
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 Adult Microporous Membrane Oxygenator With Bioline Coating ..., QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH… - FDA.report, www.accessdata.fda.gov, fda.innolitics.com, 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 | K090511 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
- FDA Applicant
- Maquet Cardiopulmonary, AG
Sources (1)
- FDA 510(k) K090511 24 fields · synced Oct 6, 2026