Target Eluting Coronary Stent System - India CDSCO Medical Device Registration
Target Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000366_6cd021cdc05a98e1d17375de78458475_7f3d99ff39486b73d62b9a489f9a595a. This device is marketed under the brand name FirehawkTM Rapamycin Target Eluting Coronary Stent System. The license holder is MicroPort Scientific India Pvt. Ltd., ,Shop No. 9, Kamla Palace, Civil Line, Barfkhana ,Gurgaon Haryana ,122001 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
FirehawkTM Rapamycin Target Eluting Coronary Stent System
License Holder
MicroPort Scientific India Pvt. Ltd., ,Shop No. 9, Kamla Palace, Civil Line, Barfkhana ,Gurgaon Haryana ,122001 ,IndiaDevice Class
Approving Authority
CDSCO
Product Information
The 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.
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