Carotid Embolic Prevention Stent System - India CDSCO Medical Device Registration
Carotid Embolic Prevention Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000157_50f1dee6de9ab42c89be05b0f31cdfd7_77066f0de2434ba57298db28e7ceefbd. This device is marketed under the brand name CGuard. The license holder is Hester Diagnostics Pvt. Ltd., ,Office No. 213/214/214 A/215/216, Jolly Bhavan No. 1, 2nd Floor, 10, New Marine Lines, Taluka Marine Line, District Mumbai Zone1 ,Mumbai City Maharashtra ,400020 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
CGuard
Device Class
Approving Authority
CDSCO
Product Information
The CGuard EPS is indicated for: Improving carotid luminal diameter in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet both criteria outlined below: • Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by either ultrasound or angiogram or patients without neurological symptoms and > 80% stenosis of the common or internal carotid artery by either ultrasound or angiogram. • Patients having a vessel with reference diameters between 4.8 mm and 9.0 mm at the target lesion.
