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FDA 510(k), K071774, JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
FDA 510(k), K071774, JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
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510(K) Number: K071774
Device Name: JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
Manufacturer: KATRIN SCHWENKGLENKS
Device Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: DTZ
Classification Product Code: 06/29/2007
Date Received: 01/23/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
Manufacturer: KATRIN SCHWENKGLENKS
Device Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: DTZ
Classification Product Code: 06/29/2007
Date Received: 01/23/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks
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