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CDSCO UID IMP/MD/2018/000061_a1de12f56e060727f287a5982c54e0ae_d7e1898f7d405baa0db1b3e0b3665ab6

Intravascular Guiding 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_a1de12f56e060727f287a5982c54e0ae_d7e1898f7d405baa0db1b3e0b3665ab6
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
The CrossBoss Catheter is intended for use with a guidewire to access discrete regions of the coronary vasculature. When used as part of the system consisting of the CrossBoss Catheter, Stingray™ LP Catheter, and Stingray Guidewire, the CrossBoss Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (NC Quantum Apex Monorail PTCA Dilatation Catheter) prior to PTCA or stent intervention
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About this record

Intravascular Guiding Catheter, single use device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_a1de12f56e060727f287a5982c54e0ae_d7e1898f7d405baa0db1b3e0b3665ab6. 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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