Rapamycin Target Eluting Coronary Stent System - India CDSCO Medical Device Registration

Rapamycin Target Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000368_3fba776a36a187f3455d08ebc1c9c9c2_e211345ad11f9be9c3d5256f60b71039. This device is marketed under the brand name FirehawkTM Rapamycin Target Eluting Coronary Stent System. The license holder is Reinvent Medical Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Rapamycin Target Eluting Coronary Stent System

UID: IMP/MD/2019/000368_3fba776a36a187f3455d08ebc1c9c9c2_e211345ad11f9be9c3d5256f60b71039

Brand Name

FirehawkTM Rapamycin Target Eluting Coronary Stent System

License Holder

Reinvent Medical Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Firehawk LibertyTM Rapamycin Target Eluting Coronary Stent System (FirehawkTM Rapamycin Target Eluting Coronary Stent System) is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions length 60 mm with reference vessel diameters of 2.25 to 4.0 mm.