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Vascular guide-catheter, single-use - India CDSCO Medical Device Registration

Vascular guide-catheter, single-use is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000061_8da66749eae30168b815cf61cafdccc7_78433881a439b1d055e99f44cb1b822f. 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
Vascular guide-catheter, single-use
UID: IMP/MD/2018/000061_8da66749eae30168b815cf61cafdccc7_78433881a439b1d055e99f44cb1b822f

Brand Name

NC Quantum Apex Monorail PTCA Dilatation Catheter

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Stingray LP Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary vasculature. When used as part of the System consisting of the CrossBossโ„ข Catheter, Stingray LP Catheter and Stingray Guidewire, the Stingray LP 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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