Coronary Stent System - India CDSCO Medical Device Registration

Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000134_0f0e5f038f5f9be051a98a006bceff3e_74ff44766c3fad29ae059f2eb5bf38d8. This device is marketed under the brand name Yukon Choice 4. The license holder is Translumina Therapeutics LLP, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Coronary Stent System

UID: IMP/MD/2020/000134_0f0e5f038f5f9be051a98a006bceff3e_74ff44766c3fad29ae059f2eb5bf38d8

Brand Name

Yukon Choice 4

License Holder

Translumina Therapeutics LLP

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Yukon® Choice 4 stent system is indicated for intraluminal chronic placement in stenosed coronary artery or aorto-coronary bypass grafts or the tibial anterior and posterior artery of the lower limb with a maximum lesion length of 45 mm, in order to obtain vessel patency following acute or subacute artery obstruction. It is also indicated in restenosis or arterial dissection after PTCA procedures. Patients being considered for stent implantation should be acceptable candidates for balloon angioplasty

Class D

Brand: Racer PC

Class D