Dilation Catheter(ClearLine) - India CDSCO Medical Device Registration

Dilation Catheter(ClearLine) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000201_8fc7e42a8fdeeaa2cda3db90c28fd962_786f21477621304b559e87b865f488aa. This device is marketed under the brand name ClearSheath. The license holder is Newtech Medical Devices, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

Dilation Catheter(ClearLine)

UID: MFG/MD/2019/000201_8fc7e42a8fdeeaa2cda3db90c28fd962_786f21477621304b559e87b865f488aa

Brand Name

ClearSheath

License Holder

Newtech Medical Devices

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

It is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion