Femoral Arterial Cannula - India CDSCO Medical Device Registration
Femoral Arterial Cannula is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000111_3bd86b908203330895c2a34ffffcdb19_ae4c8edc8d30222309069770268c8244. This device is marketed under the brand name OptiSite Arterial Perfusion Cannula. The license holder is Edwards Lifesciences (India) Private Limited,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
OptiSite Arterial Perfusion Cannula
License Holder
Edwards Lifesciences (India) Private Limited,Device Class
Approving Authority
CDSCO
Product Information
Edwards Lifesciences femoral arterial access cannulae are intended for use in situations which require rapid femoral arterial access for short-term (OptiSite Arterial Perfusion Cannula) cardiopulmonary bypass. Femoral vessel access is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo treatment are intended for use in cardiopulmonary bypass when a heparin treated cannula is desired upon initial placement
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