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/2021/000044_c886342981bcc73e66945710b8f82d9c_3a2b7b9a8f8d838cc3721fa8da3b66c9. This device is marketed under the brand name MCS. 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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Brand Name
MCS
License Holder
Faith Biotech Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The Scepter C and Scepter XC Occlusion Balloon Catheters are intended: • For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheters provide 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 diameter of the Scepter C/XC Balloon Catheter
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