Pure Global
CDSCO UID IMP/MD/2018/000061_fe0d0ac97956c47ddc438e4b8ebd0320_653452934720f66f203c46a916c8b1e1

Catheter, Balloon; 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_fe0d0ac97956c47ddc438e4b8ebd0320_653452934720f66f203c46a916c8b1e1
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 Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature
Similar products (9)
Other products with the same name or brand
Catheter, Angioplasty, Balloon Dilatation, basic, Single use devices
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Catheter, Angioplasty, Balloon Dilatation, basic, Single Use device
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Intravascular Guiding Catheter, single use device
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Vascular guide-catheter, single-use
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Embolectomy/Thrombectomy Suction Catheter; Single Use device
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Intravascular Haemodynamic Monitoring System Guidewire
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Catheter, Coronary, Guide, Single Use Device
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Coronary angioplasty balloon catheter, basic
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Catheter, Angioplasty, Balloon Dilatation, basic; Single Use devices
Brand: NC Quantum Apex Monorail PTCA Dilatation Catheter
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
Class D
Other products from 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
Products from the same license holder (10 products)
Holmium Laser Fiber
Brand: Moses
Class C
Holmium Laser Fiber
Brand: SlimLine
Class C
CO2 Laser Fiber
Brand: SlimLine
Class C
Holmium Laser Fiber
Brand: Lumenis Pulse 100H
Class C
Tissue Morcellator
Brand: VersaCut Tissue Morcellator
Class B
Holmium Laser System
Brand: Lumenis Pulse 100H
Class C
Holmium Laser System
Brand: Lumenis Pulse 100H
Class C
CO2 Laser Fiber
Brand: Lumenis Pulse 100H
Class C
Holmium Laser system
Brand: Lumenis Pulse 100H
Class C
CO2 Laser System
Brand: Lumenis Pulse 100H
Class C
About this record

Catheter, Balloon; Single Use Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_fe0d0ac97956c47ddc438e4b8ebd0320_653452934720f66f203c46a916c8b1e1. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.