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CDSCO UID IMP/MD/2018/000061_ad385d73974b2f5492610e9320f0ee13_58f48720e3d0e90dd557865f1b66c6d2

Peripheral angioplasty balloon catheter, basic

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·Device Class Class B·India CDSCO·Brand: Rubicon 18 Support Catheter
Registration details
UID
IMP/MD/2018/000061_ad385d73974b2f5492610e9320f0ee13_58f48720e3d0e90dd557865f1b66c6d2
Device class
Class B
Brand name
Rubicon 18 Support Catheter
License holder
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
Approving authority
CDSCO
Product information
The Sterling SL OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (Rubicon 18 Support Catheter) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae
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About this record

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_ad385d73974b2f5492610e9320f0ee13_58f48720e3d0e90dd557865f1b66c6d2. 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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