PTA Rapid Exchange Balloon Dilation Catheter - India CDSCO Medical Device Registration

PTA Rapid Exchange Balloon Dilation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000172_e5d13a3c494bf5dd2e4dcc189f0aff2f_cbcec43a0436d816674b60cf3be8bd5d. This device is marketed under the brand name EverCross. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

PTA Rapid Exchange Balloon Dilation Catheter

UID: IMP/MD/2018/000172_e5d13a3c494bf5dd2e4dcc189f0aff2f_cbcec43a0436d816674b60cf3be8bd5d

Brand Name

EverCross

License Holder

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

Device Class

Class B

Approving Authority

CDSCO

Product Information

It is intended to dilate stenoses in the iliac, femoral, ilio- femoral, popliteal, intra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature,0.035 OTW PTA Dilatation Catheter(EverCross)-The EverCross 0.035 OTW PTA Dilatation catheter is intended to dilate stenosis in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

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Other Products from India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

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