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510(k) Data Aggregation
K Number
K241053Device Name
MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL
Manufacturer
Medtronic Cardiac Surgery
Date Cleared
2024-05-15
(28 days)
Product Code
DTN
Regulation Number
870.4400Why did this record match?
Applicant Name (Manufacturer) :
Medtronic Cardiac Surgery
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.
Device Description
The MVR Venous Reservoir Bag, with or without Cortiva bioactive surface, is a single-use, sterile, nonpyrogenic variable volume device used in conjunction with a membrane oxygenator during cardiopulmonary bypass (CPB) surgery. It is sterilized using ethylene oxide. It is designed to accommodate blood from the patient and suctioned blood from the cardiotomy reservoir. The internal screen of the venous reservoir is designed to assist in tramping air, which may enter the venous reservoir during priming or perfusion on the inlet side of the reservoir. Air trapped in the venous reservoir bag can be removed using the one-way stopcock located at the top of the reservoir.
Blood that comes from the patient flows into the reservoir and is delivered through a pump to the oxygenator and other axillary devices, and back to the patient. The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path.
Products coated with Cortiva bioactive surface include a "CB" prefix in the model number. The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa.
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K Number
K960755Device Name
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
Manufacturer
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
Date Cleared
1996-05-23
(90 days)
Product Code
DQX
Regulation Number
870.1330Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.
Device Description
Each Medtronic CardioTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios devending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient. The Medtronic CardioTherm™ Cardioplegia Heat Exchanger consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or nonvented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery. The heat exchanger housing contains nonporous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.
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K Number
K953564Device Name
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
Manufacturer
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
Date Cleared
1996-02-02
(186 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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