PTA Balloon - India CDSCO Medical Device Registration

PTA Balloon is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000014_48dbefef2c761f15f6b3cb794dee4a0d_70dec06da071d2b0e27a8beb37878814. This device is marketed under the brand name CROSSER CTO Recanalization Catheter. The license holder is Bard India Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

PTA Balloon

UID: IMP/MD/2018/000014_48dbefef2c761f15f6b3cb794dee4a0d_70dec06da071d2b0e27a8beb37878814

Brand Name

CROSSER CTO Recanalization Catheter

License Holder

Bard India Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The UltraScore™ Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature