Thermodilution Catheters - India CDSCO Medical Device Registration

Thermodilution Catheters is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000344_0de770d2830273e5eadb2b792ed8f2b5_d759b13ccbd89eb3f96145aab1f9a341. This device is marketed under the brand name Swan-Ganz CCO, Swan-Ganz CCO V, Swan-Ganz CCOmbo, Swan-Ganz CCOmbo V Thermodilution Catheters. 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

Thermodilution Catheters

UID: IMP/MD/2018/000344_0de770d2830273e5eadb2b792ed8f2b5_d759b13ccbd89eb3f96145aab1f9a341

Brand Name

Swan-Ganz CCO, Swan-Ganz CCO V, Swan-Ganz CCOmbo, Swan-Ganz CCOmbo V Thermodilution Catheters

License Holder

Edwards Lifesciences (India) Private Limited,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The CCO/CEDV thermodilution catheter series is for use in patients who require hemodynamic monitoring. They are intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with a compatible cardiac output computer to continuously measure cardiac output. Models 744F75, 746F8, 774F75, and 777F8 also measure mixed venous oxygen saturation. When used with the compatible cardiac output computer, models 177F75N, 774F75, and 777F8 also measure volumetric parameters, including right ventricular ejection fraction and end diastolic volume