Occlusion Balloon Catheter - India CDSCO Medical Device Registration

Occlusion Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000125_c886342981bcc73e66945710b8f82d9c_1b00ca5658b8d1cf9db3a403387d1755. This device is marketed under the brand name VIA. The license holder is Faith Biotech 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

Occlusion Balloon Catheter

UID: IMP/MD/2021/000125_c886342981bcc73e66945710b8f82d9c_1b00ca5658b8d1cf9db3a403387d1755

Brand Name

VIA

License Holder

Faith Biotech Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Scepter Mini Occlusion Balloon Catheter is intended: • For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheters also offer balloon assisted embolization of intracranial aneurysms. • For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents such as embolization materials. • For neurovascular use for the infusion of diagnostic agents such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner lumen of the Scepter Mini Occlusion Balloon Catheter.

Class D

Brand: Flow Re-Direction Endoluminal Device

Class D