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0.035 OTW PTA Dilatation Catheter - India CDSCO Medical Device Registration

0.035 OTW PTA Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000172_d3b0752ee3f092e1bed3283c04f1e165_5d28db38fbf1d4f73a886fe9a4cc1e75. 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
0.035 OTW PTA Dilatation Catheter
UID: IMP/MD/2018/000172_d3b0752ee3f092e1bed3283c04f1e165_5d28db38fbf1d4f73a886fe9a4cc1e75

Brand Name

EverCross

Device Class

Class B

Approving Authority

CDSCO

Product Information

The EverCross 0.035 OTW PTA Dilatation catheter is intended to dilate stenosis in the iliac, femoral, ilioยญfemoral, 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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