PTA Balloon Catheter - India CDSCO Medical Device Registration
PTA Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000419_b101711203cae2fa44c17ced25f85b10_4cea8b8cc3659b535884cee8b00728f7. This device is marketed under the brand name Fortrexโข HP PTA Balloon Catheter. 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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Brand Name
Fortrexโข HP PTA Balloon Catheter
Device Class
Approving Authority
CDSCO
Product Information
The Fortrex HP PTA Balloon Catheter is intended to dilate stenoses 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.
PTA Balloon Catheter
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