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_431154b22f3b9694a8cf747878abee01. 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_431154b22f3b9694a8cf747878abee01

Brand Name

Introducer Sheath Set

License Holder

Rukman Medical Devices And Equipments Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

Tri-Wedge PTA is indicated to dilate stenosis in the iliac, femoral, iliofemoral, pepliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialyis fistulae