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/2018/000031_b101711203cae2fa44c17ced25f85b10_4e95068b8c740ee6c7610fee6d6d2d6f. This device is marketed under the brand name LifeStream Balloon Expandable Vascular Covered Stent. 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 Catheter

UID: IMP/MD/2018/000031_b101711203cae2fa44c17ced25f85b10_4e95068b8c740ee6c7610fee6d6d2d6f

Brand Name

LifeStream Balloon Expandable Vascular Covered Stent

License Holder

Bard India Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The ReeKross PTA Balloon Catheters are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries

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