Cobalt Chromium Coronary Stent Delivery System - India CDSCO Medical Device Registration

Cobalt Chromium Coronary Stent Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000086_ccdd0b64f12c7c67c537f938e6f67542_21760898122ef07b9d8847b6bc44b62d. This device is marketed under the brand name TRICVALVE/ TREBLE/ TRICHOTOMIC/ TRIO/ TRICUSPIDEM. The license holder is Relisys Medical Devices Limited, and it is classified as Device Class Class D. The approving authority is CDSCO, Zonal office, Hyderabad.

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CDSCO Registered

Class Class D

Cobalt Chromium Coronary Stent Delivery System

UID: MFG/MD/2020/000086_ccdd0b64f12c7c67c537f938e6f67542_21760898122ef07b9d8847b6bc44b62d

Brand Name

TRICVALVE/ TREBLE/ TRICHOTOMIC/ TRIO/ TRICUSPIDEM

License Holder

Relisys Medical Devices Limited

Device Class

Class D

Approving Authority

CDSCO, Zonal office, Hyderabad

Product Information

The Relisys Cobalt chromium coronary stent system is indicated for improving luminal diameter and reducing restenosis for the treatment of de novo lesions in native coronary arteries in the following: • Patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions • Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts. • Restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by ST-segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions