Balloon Catheter - India CDSCO Medical Device Registration

Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000544_8ed9cb6bdc14ce1ac902f2894708b919_68c94c6b518b1c5b7dcca7afd683729d. This device is marketed under the brand name Chameleon PTA Balloon Catheter with Injection Port. 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

Balloon Catheter

UID: IMP/MD/2021/000544_8ed9cb6bdc14ce1ac902f2894708b919_68c94c6b518b1c5b7dcca7afd683729d

Brand Name

Chameleon PTA Balloon Catheter with Injection Port

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

The Chameleon™ PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty for the peripheral vasculature, including the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon™ enables the infusion of diagnostic or therapeutic fluids. The catheter is not for use in coronary arteries or cerebral 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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