PTA Dilatation Catheter - India CDSCO Medical Device Registration

PTA Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000113_d7017d691f34d40cafe0f76a3378c108_12eb217282d0ecfd064691d7336f3c7c. This device is marketed under the brand name Sleek. The license holder is Cardinal Health Medical Products India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

PTA Dilatation Catheter

UID: IMP/MD/2022/000113_d7017d691f34d40cafe0f76a3378c108_12eb217282d0ecfd064691d7336f3c7c

Brand Name

Sleek

License Holder

Cardinal Health Medical Products India Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Sleek® OTW PTA balloon catheter are intended for balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.