PTCA Balloon Catheter - India CDSCO Medical Device Registration

PTCA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000368_35f2171fa613585bd5d0311eff170695_5cfab9682f0c897c7b0648fb5560f7c2. 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

PTCA Balloon Catheter

UID: IMP/MD/2019/000368_35f2171fa613585bd5d0311eff170695_5cfab9682f0c897c7b0648fb5560f7c2

Brand Name

FirehawkTM Rapamycin Target Eluting Coronary Stent System

License Holder

Reinvent Medical Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; Balloon dilatation of a stent after Implantation