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CDSCO UID IMP/MD/2018/000061_8cfc5fabafb7fb7e6da8cee69c21d330_9100126648c7970bcbf7f4513ad9eac3

Embolectomy/Thrombectomy Suction 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 D·India CDSCO·Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
Registration details
UID
IMP/MD/2018/000061_8cfc5fabafb7fb7e6da8cee69c21d330_9100126648c7970bcbf7f4513ad9eac3
Device class
Class D
Brand name
NC Quantum Apex Monorail PTCA Dilatation 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
It is intended for use with the AngioJet System in breaking apart and removing thrombus from: • main pulmonary and lobar arteries greater than or equal to 6 mm in diameter, • for use with the AngioJet Power Pulse Technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the pulmonary vasculary system
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About this record

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_8cfc5fabafb7fb7e6da8cee69c21d330_9100126648c7970bcbf7f4513ad9eac3. This device is marketed under the brand name NC Quantum Apex Monorail PTCA Dilatation 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 D. The approving authority is CDSCO.

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