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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/2021/000693_48dbefef2c761f15f6b3cb794dee4a0d_b6fdcb9af068d3536c5b7ccf60d58166. This device is marketed under the brand name CROSSER CTO Recanalization Catheter. The license holder is Becton Dickinson India Private Limited, 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/2021/000693_48dbefef2c761f15f6b3cb794dee4a0d_b6fdcb9af068d3536c5b7ccf60d58166

Brand Name

CROSSER CTO Recanalization Catheter

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.

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