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CDSCO UID IMP/MD/2018/000061_7883f00fc58c57c1ea0ef0bf0e3f3575_865001c0c5be565d6dc6646818c40711

Balloon peripheral angioplasty catheter, Single Use device

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_7883f00fc58c57c1ea0ef0bf0e3f3575_865001c0c5be565d6dc6646818c40711
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 Coyote 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
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About this record

Balloon peripheral angioplasty catheter, Single Use device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_7883f00fc58c57c1ea0ef0bf0e3f3575_865001c0c5be565d6dc6646818c40711. 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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