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/2019/000509_b101711203cae2fa44c17ced25f85b10_f3bed50c0f59ae01981a17a378a9a842. This device is marketed under the brand name Indigo. The license holder is ORIENT MEDICAL DISTRIBUTORS, and it is classified as Device Class Class C. The approving authority is CDSCO.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
Indigo
License Holder
ORIENT MEDICAL DISTRIBUTORSDevice Class
Approving Authority
CDSCO
Product Information
The PTA Balloon catheter is intended for use in percutaneous transluminal angioplasty of femoral , illiac, renal arteries or post deployment dilation of peripheral vascular stents or for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae
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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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Brand: LifeStream Balloon Expandable Vascular Covered Stent
Bard India Healthcare Pvt. Ltd.

