Paclitaxel eluting coronary balloon dilatation catheter - India CDSCO Medical Device Registration
Paclitaxel eluting coronary balloon dilatation catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000166_94bf5b2d9fa71adf051fb015e9552979_6875a55d5793417a9a86dc730a745173. This device is marketed under the brand name iVascular navitian. The license holder is M/s Luminor Medical Devices Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
iVascular navitian
License Holder
M/s Luminor Medical Devices Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The device is indicated for the dilatation of stenosis or coronary artery or bypass grafts occlusions, including small vessels, as well as for residual stenosis after treatment with balloon or endoprosthesis and pre- and post-dilation of coronary endovascular prosthesis, in order to improve myocardial perfusion.
