Jostra Quadrox D Diffusion Membrane Oxygenator With Bioline Coating, Model Be-H…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071774 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 Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating is a diffusion membrane oxygenator designed for extracorporeal circulation during cardiopulmonary bypass. It facilitates gas exchange by diffusing oxygen into and carbon dioxide out of blood, ensuring adequate oxygenation and decarboxylation during open-heart surgical procedures. The Bioline coating enhances biocompatibility, reducing hemolysis and thrombus formation while maintaining efficient oxygen transfer.
This device is supplied as a single-use, sterile product and is intended for use in controlled surgical environments such as operating rooms. It is classified under FDA regulation 870.4350 and has received FDA 510(k) clearance (K071774) as substantially equivalent to a predicate device. Models BE-HMOD 2000 and BEQ-HMOD 2030 are available, with no MRI safety restrictions noted. Proper storage requires adherence to manufacturer guidelines to preserve sterility and functionality.
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: Jostra Quadrox D Diffusion Membrane Oxygenator With Bioline Coating ..., Jostra Quadrox D Diffusion Membrane Oxygenator With Bioline Coating ..., www.accessdata.fda.gov, Jostra Quadrox D Diffusion Membrane Oxygenator With Bioline Coating ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071774 | Class II | Active |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
- FDA Applicant
- Maquet Cardiopulmonary, AG
Sources (1)
- FDA 510(k) K071774 24 fields · synced Oct 6, 2026