Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration

Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000227_f8b931cbeba5223f0f867acdf6ecb93f_b1935f9412eec445970ed61d888b3782. This device is marketed under the brand name Racer PC. The license holder is Translumina Therapeutics LLP, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Sirolimus Eluting Coronary Stent System

UID: MFG/MD/2019/000227_f8b931cbeba5223f0f867acdf6ecb93f_b1935f9412eec445970ed61d888b3782

Brand Name

Racer PC

License Holder

Translumina Therapeutics LLP

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Vivo ISAR-Polymer Free Sirolimus Eluting Coronary Stent System used for treatment of: - Symptomatic coronary artery disease due to discrete de novo or restenosis lesion in native coronary artery. - Symptomatic coronary artery disease due to culprit lesion in saphenous vein graft. - Treatment of Coronary lesion in patients undergoing primary or rescue PCI for acute ST segment elevation myocardial infarction (Racer PC) Treatment of coronary lesion having athero thrombotic appearance in patients with non ST-elevation acute coronary syndromes (Racer PC)

Class D

Semi-Compliant PTCA Balloon catheter

Brand: Racer PC

Translumina Therapeutics LLP

Class D

Brand: Racer PC

Class D