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/2022/000042_3bd86b908203330895c2a34ffffcdb19_3b51f451accb90fc6bc4bdbd45fde824. This device is marketed under the brand name Fem-Flex II™ Femoral Arterial 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 Arterial Cannula

UID: IMP/MD/2022/000042_3bd86b908203330895c2a34ffffcdb19_3b51f451accb90fc6bc4bdbd45fde824

Brand Name

Fem-Flex II™ Femoral Arterial Cannula

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

Edwards Lifesciences Femoral Arterial Cannulae are intended for use in situations which require rapid femoral arterial access for short-term (Fem-Flex II™ Femoral Arterial Cannula) cardiopulmonary bypass. 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