Bare Metal Stent System - India CDSCO Medical Device Registration

Bare Metal Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000227_ccfa10c09d91d088f9a4c52390716890_4bc3deed4b248d60945b2c8fc68f31e9. 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

Bare Metal Stent System

UID: MFG/MD/2019/000227_ccfa10c09d91d088f9a4c52390716890_4bc3deed4b248d60945b2c8fc68f31e9

Brand Name

Racer PC

License Holder

Translumina Therapeutics LLP

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Flaxon-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 48 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

Class D

Semi-Compliant PTCA Balloon catheter

Brand: Racer PC

Translumina Therapeutics LLP

Class D

Brand: Racer PC

Class D