Non-compliant PTA Balloon Dilatation Catheter - India CDSCO Medical Device Registration

Non-compliant PTA Balloon Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000134_af6882c2cf9162dfe62c8b1c0a9ce3f0_373ba6b00a9c3849a09970fdfa9c4e61. This device is marketed under the brand name Introducer Sheath Set. The license holder is Rukman Medical Devices And Equipments 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

Non-compliant PTA Balloon Dilatation Catheter

UID: IMP/MD/2019/000134_af6882c2cf9162dfe62c8b1c0a9ce3f0_373ba6b00a9c3849a09970fdfa9c4e61

Brand Name

Introducer Sheath Set

License Holder

Rukman Medical Devices And Equipments Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The PTA balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.