PTA Balloon Catheter - India CDSCO Medical Device Registration
PTA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000557_b101711203cae2fa44c17ced25f85b10_e067f072108e97f1d3e02cdb11cad779. This device is marketed under the brand name GM-30 Inflation Device. The license holder is NIPRO MEDICAL (INDIA) PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
GM-30 Inflation Device
License Holder
NIPRO MEDICAL (INDIA) PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
This device is used for percutaneous transluminal angioplasty (GM-30 Inflation Device) to dilate a stenotic lesion in peripheral arteries and stenotic lesions of arteriovenous dialysis fistula, whereby it is considered that dilatation of a conventional balloon would result in inadequate lesion expansion. This device is not for use in the coronary and intracranial vessels including carotid arteries
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