Transcatheter Bicaval Valves System - India CDSCO Medical Device Registration

Transcatheter Bicaval Valves System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000086_b8f137a1a534097f0fa072adde9149ac_2206c364c8def784cf0cbaf1de43d08c. This device is marketed under the brand name TRICVALVE/ TREBLE/ TRICHOTOMIC/ TRIO/ TRICUSPIDEM. The license holder is Relisys Medical Devices Limited, and it is classified as Device Class Class D. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered

Class Class D

Transcatheter Bicaval Valves System

UID: MFG/MD/2020/000086_b8f137a1a534097f0fa072adde9149ac_2206c364c8def784cf0cbaf1de43d08c

Brand Name

TRICVALVE/ TREBLE/ TRICHOTOMIC/ TRIO/ TRICUSPIDEM

License Holder

Relisys Medical Devices Limited

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

Transcatheter Bicaval Valves is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The bioprosthesis are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. It is especially intended for use in patients at extreme risk or who are inoperable for open surgical therapy