Guide Catheter - India CDSCO Medical Device Registration

Guide Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000375_ee9ac98ac4216554f538c58984d541a5_834f6ef0d7dbb5b5c8e8c252cd859491. This device is marketed under the brand name Acuity Pro. 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

Guide Catheter

UID: IMP/MD/2022/000375_ee9ac98ac4216554f538c58984d541a5_834f6ef0d7dbb5b5c8e8c252cd859491

Brand Name

Acuity Pro

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

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 (Acuity Pro) or in dual catheter delivery (Acuity Pro). 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.