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Peripheral Angioplasty Balloon Catheter - Basic - India CDSCO Medical Device Registration

Peripheral Angioplasty Balloon Catheter - Basic is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_a8c654c53c3eac5506a767a904276df5_82798fffb411510ac19149a716157f7a. This device is marketed under the brand name Rubicon 18 Support Catheter. The license holder is Boston Scientific India Private Limited ,C/o Parekh Integrated Services Pvt.Ltd., 1st Floor, Khasra Nos. 9//12/3 min (3-17), 13/3min (5-7), 18(8-0), 19min (5-16), 22min (5-16), 23(8-0), 13//2min (5-16), 3 (8-0), Village Bhangrola, Sector M-12 ,Gurgaon Haryana ,122505 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Peripheral Angioplasty Balloon Catheter - Basic
UID: IMP/MD/2018/000061_a8c654c53c3eac5506a767a904276df5_82798fffb411510ac19149a716157f7a

Brand Name

Rubicon 18 Support Catheter

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (Rubicon 18 Support Catheter) in the peripheral vasculature, including iliac, femoral, 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 post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature

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