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Embolectomy/Thrombectomy Suction Catheter; Single use device - India CDSCO Medical Device Registration

Embolectomy/Thrombectomy Suction Catheter; Single use device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_e2cb40ea1ab93bcd4901aee96b68d56d_772b4fa8257a8aa8dbf8882b86e18030. This device is marketed under the brand name Express Vascular SD Premounted Stent System. 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 C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Embolectomy/Thrombectomy Suction Catheter; Single use device
UID: IMP/MD/2018/000061_e2cb40ea1ab93bcd4901aee96b68d56d_772b4fa8257a8aa8dbf8882b86e18030

Brand Name

Express Vascular SD Premounted Stent System

Device Class

Class C

Approving Authority

CDSCO

Product Information

The AngioJet Solent Omni Thrombectomy Sets are intended for use with the AngioJet Ultra Console to break apart and remove thrombus from: โ€ข upper and lower extremity peripheral arteries greater than or equal to 3.0 mm in diameter, โ€ข upper extremity peripheral veins greater than or equal to 3.0 mm in diameter, โ€ข ileofemoral and lower extremity veins greater than or equal to 3.0 mm in diameter, โ€ข A-V access conduits greater than or equal to 3.0 mm in diameter and โ€ข for use with the AngioJet Ultra Power Pulseโ„ข technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

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Embolectomy/Thrombectomy Suction Catheter; Single Use device

Brand: Express Vascular SD Premounted Stent System

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

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Brand: Express Vascular SD Premounted Stent System

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

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