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510(k) Data Aggregation
K Number
K112975Device Name
CARBONAID C02 DIFFUSER
Manufacturer
CARDIA INNOVATION AB
Date Cleared
2012-06-22
(261 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
CARDIA INNOVATION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CarbonAid® CO2 diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism which can result in organ damage.
Device Description
The CarbonAid®CO2 diffuser is a disposable surgical device for effective insufflation of carbon dioxide (CO2) into an open surgical wound to create a topical atmosphere of 100% CO2 during open heart surgery. Air will enter in the heart and great vessels during conventional open heart surgery and is difficult to evacuate with current de-airing techniques. Trapped air will be mobilized to the arterial vessels during weaning from cardiopulmonary bypass and will thus embolize to the brain and other organs. Since air dissolves poorly in blood and tissue, air bubbles will obstruct blood flow and cause tissue hypoxia and injury. CO2 is more than 25 times more soluble than air in blood and tissue and arterial CO2 emboli will thus be fewer, dissolve more quickly and decrease the risk of organ injury. A 100% CO2 atmosphere can be created and maintained in an open surgical wound, since CO2 is 50% heavier (denser) than air, provided that tube transports the CO2 gas from the gas source/humidifier to the surgical wound and has the standard width / internal diameter of medical tubes for this purpose (¼ inch). The hydrophobic gas filter (pore size <0.2um) prevents cross-contamination between the gas source/humidifier* and the wound. The thinner tube contains a stainless steel wire and stabilizes the gas diffuser inside the wound. The gas diffuser is made of medical foam plastic that is connected to the thin tube via a plastic disc. The disc also provides a large bonding area for the foam plastic and encapsulates the distal end of the stainless steel wire. The gas diffuser reduces the outflow velocity of the gas thus enabling a high flow at a very low outflow velocity. The elastic and hydrophobic properties of the foam plastic helps to maintain the full function of the gas diffuser and reduces the risk of foaming when the diffuser gets in contact with fluids including blood.
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K Number
K052125Device Name
CARBONAID GAS DIFFUSER
Manufacturer
CARDIA INNOVATION AB
Date Cleared
2006-02-08
(187 days)
Product Code
HIF
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
CARDIA INNOVATION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CarbonAid™ gas diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism.
Device Description
The CarbonAid™ gas diffuser is a disposable surgical device for effective insufflation of carbon dioxide (CO2) into an open surgical wound to create a topical atmosphere of 100% CO2. The larger tube transports the gas from the gas source/humidifier to the surgical wound and has the standard width of medical tubes for this purpose (14 inch). The hydrophobic gas filter (≤0.2µm) prevents cross-contamination between the aas source/humidifier and the wound. The thinner tube contains a stainless steel wire and stabilizes the gas diffuser inside the wound. The gas diffuser is made of medical foam plastic (with open cells, 30 kg/m3) that is connected to the thin tube via a plastic disc
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