Guiding Catheter - India CDSCO Medical Device Registration

Guiding Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000453_4a3bde928746e7ba76767a3a82ddd409_185ea9e2f523a7170a02cd8d49e9eb12. This device is marketed under the brand name Sherpa NX Balanced. 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 D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Guiding Catheter

UID: IMP/MD/2020/000453_4a3bde928746e7ba76767a3a82ddd409_185ea9e2f523a7170a02cd8d49e9eb12

Brand Name

Sherpa NX Balanced

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 D

Approving Authority

CDSCO

Product Information

Medtronic guide catheters are intended to provide a pathway through which diagnostic or therapeutic devices are introduced during percutaneous procedures including interventions in coronary arteries (Sherpa NX Balanced), non-intracranial carotid arteries, brachiocephalic arteries, pulmonary arteries, aorto-abdominal branches or peripheral arteries (Sherpa NX Balanced)

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