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Intravascular guiding catheter - India CDSCO Medical Device Registration

Intravascular guiding catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000389_328a516ab3d49035b9ba0b5446b58fed_bfcef27a7d4e2ae5804b69eed4a43c62. This device is marketed under the brand name Mach1 Guide Catheters. 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
Intravascular guiding catheter
UID: IMP/MD/2019/000389_328a516ab3d49035b9ba0b5446b58fed_bfcef27a7d4e2ae5804b69eed4a43c62

Brand Name

Mach1 Guide Catheters

Device Class

Class D

Approving Authority

CDSCO

Product Information

Boston Scientific Guide Catheters provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature. Boston Scientific Peripheral Guide Catheters are intended for use in general intravascular and peripheral applications. Boston Scientific Coronary Guide Catheters are intended for use in general intravascular and coronary applications

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