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510(k) Data Aggregation
K Number
K231414Device Name
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
Manufacturer
Chalice Medical Ltd
Date Cleared
2023-11-01
(169 days)
Product Code
DTZ, DTR, DWF
Regulation Number
870.4350Why did this record match?
Applicant Name (Manufacturer) :
Chalice Medical Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CMO8 Adult PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The CMO8 Adult PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal crculation during cardiopulmonary bypass procedures, lasting 6 hours or less.
Device Description
The CMO8 Adult PMP oxygenator (CMO8) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The CMO8 facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The CMO8 is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The qas exchanger part of the CMO8 is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the CMO8 is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated. The Tubing Pack, which contains blood lines, gas lines, a venous reservoir and the CMO8 Oxygenator, is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.
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K Number
K201642Device Name
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
Manufacturer
Chalice Medical Ltd
Date Cleared
2020-09-18
(93 days)
Product Code
DTZ, DTR, DWF
Regulation Number
870.4350Why did this record match?
Applicant Name (Manufacturer) :
Chalice Medical Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paragon Adult Maxi PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
Device Description
The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) with Tubing Pack is a hollow fiber membrane oxygenator with an integrated heat exchanger pre-connected to blood line and gas line tubing. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the requlation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces.
The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.
The Tubing Pack is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.
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K Number
K191246Device Name
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
Manufacturer
Chalice Medical Ltd
Date Cleared
2020-02-28
(295 days)
Product Code
DTZ, DTR
Regulation Number
870.4350Why did this record match?
Applicant Name (Manufacturer) :
Chalice Medical Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours.
Device Description
The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.
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