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510(k) Data Aggregation
K Number
K182302Device Name
CardioGard Emboli Protection Cannula
Manufacturer
Date Cleared
2019-05-17
(266 days)
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CardioGard Medical Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery.
The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (<6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.
Device Description
The CardioGard Emboli Protection Cannula (CardioGard Cannula) is a sterile, single-use, disposable double lumen arterial cannula. The CardioGard Cannula features a tip configuration that diffuses oxygenated blood from the heart-lung machine into the ascending aorta through the Cannula Outlet, while also aspirating blood and embolic matter through the Suction Lumen Inlet. The flow rates through the two cannula lumens are carefully controlled so that emboli are suctioned back to the heart-lung machine for filtration while still enabling sufficient blood flow to the patient.
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K Number
K141465Device Name
CARDIOGARD EMBOLI PROTECTION CANNULA
Manufacturer
Date Cleared
2015-01-09
(220 days)
Product Code
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
CARDIOGARD MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (≤ 6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.
Device Description
The CardioGard Emboli Protection Cannula, shown below, is a disposable 24 French double lumen arterial cannula. The cannula functions to deliver oxygenated blood to the heart during procedures requiring cardiopulmonary bypass (CPB), while at the same time suctioning blood and embolic matter away from the surgical field. The arterial cannula is inserted centrally in the ascending aorta. The CardioGard Emboli Protection Cannula features a tip configuration which diffuses oxygenated blood from the heart-lung machine to the ascending aorta through the Cannula Outlet, while also aspirating blood and embolic matter through the Suction Lumen Inlet. The flow rates through the two cannula lumens are carefully controlled so that emboli are suctioned back to the CPB machine for filtration while still enabling sufficient blood flow into the aorta.
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