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510(k) Data Aggregation
K Number
K992559Device Name
HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
Manufacturer
JOSTRA BENTLEY
Date Cleared
1999-09-20
(52 days)
Product Code
DTZ
Regulation Number
870.4350Why did this record match?
Applicant Name (Manufacturer) :
JOSTRA BENTLEY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hollow Fibre Membrane Oxygenator HMO 1010 is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Device Description
The Hollow Fibre Membrane Oxygenator Quadrox HMO 1010 is a blood gas exchanger with integrated heat exchanger. In open heart surgery it is used in an extracorporeal perfusion circuit first to oxygenate blood and remove carbondioxide second to regulate the blood temperature during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The oxygenation system is principally based on microporous polypropylene hollow fiber membranes. The heat exchanger is made of thight polyethylene fibers. The QUADROX consists of two membrane compartments. In the first chamber of the oxygenator, sheets of heat exchanger fibers and sheets of microporous oxygenation fibers are arranged crosswise. In the second chamber only sheets of the oxygenation fibers are arranged.
Blood enters the housing via the inlet connector and is distributed into a pre-chamber. Then the blood streams through the membrane package. In the first section it is tempered and oxygenated. In the second part only oxygenation and removal of carbondioxide takes place.
Positioned and integrated at the top of the oxygenator is a de-airing membrane. This membrane is a hydrophobic membrane allowing only gaseous substances to pass through the membrane but fluids are held back. The de-airing membrane allows easier priming, deairing and elimination of air throughout the whole procedure. To prime the oxygenator the Luer cap has to be removed. It should be kept open during perfusion to eliminate air continuously.
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K Number
K984338Device Name
JOSTRA HL-20 TWIN PUMP
Manufacturer
JOSTRA BENTLEY
Date Cleared
1999-08-19
(259 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
JOSTRA BENTLEY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jostra HL-20 Twin Pump is intended for use as an extra corporeal circulation device for perfusion appropriate to cardiopulmonary bypass procedures of six hours or less. It is only intended for use with the Jostra HL-20 Heart Lung Machine.
Device Description
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