Femoral Venous Cannula - India CDSCO Medical Device Registration

Femoral Venous Cannula is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000111_6d56b0e31b8121c040a6611670d79f33_92e3bd8d0b11c85c73fd2fab8f76b54d. 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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CDSCO Registered

Class Class D

Femoral Venous Cannula

UID: IMP/MD/2018/000111_6d56b0e31b8121c040a6611670d79f33_92e3bd8d0b11c85c73fd2fab8f76b54d

Brand Name

OptiSite Arterial Perfusion Cannula

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

Edwards Lifesciences femoral venous access cannulae are intended for use in situations which require rapid femoral venous 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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Class B