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Catheter, Coronary, Guide, Single Use Device - India CDSCO Medical Device Registration

Catheter, Coronary, Guide, Single Use Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_4fdc94b3dd82a4e37b858f26477b392a_a75a78178a31d8700183a1c620810387. 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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CDSCO Registered
Class Class D
Catheter, Coronary, Guide, Single Use Device
UID: IMP/MD/2018/000061_4fdc94b3dd82a4e37b858f26477b392a_a75a78178a31d8700183a1c620810387

Brand Name

NC Quantum Apex Monorail PTCA Dilatation Catheter

Device Class

Class D

Approving Authority

CDSCO

Product Information

The ACUITY Pro Lead Delivery System is intended to access the coronary venous system, and may be used alone (NC Quantum Apex Monorail PTCA Dilatation Catheter) or in dual catheter delivery (NC Quantum Apex Monorail PTCA Dilatation Catheter). The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system

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