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CDSCO UID MFG/MD/2023/000591_13b6443d1c38de8cb3a6f873057de196_aa2cb9af4bc983f4d487c61ea56cc5f6

Drug Coated dilation catheter

CARDIOAXIS CORPORATION PVT LTD C/O FRISCH MEDICAL DEVICES PVT LTD·Device Class Class D·India CDSCO·Brand: Sirolimus
Registration details
UID
MFG/MD/2023/000591_13b6443d1c38de8cb3a6f873057de196_aa2cb9af4bc983f4d487c61ea56cc5f6
Device class
Class D
Brand name
Sirolimus
License holder
CARDIOAXIS CORPORATION PVT LTD C/O FRISCH MEDICAL DEVICES PVT LTD
Approving authority
Central Drug Standards Control Organization, West Zone
Product information
It is intended for balloon dilation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
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About this record

Drug Coated dilation catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000591_13b6443d1c38de8cb3a6f873057de196_aa2cb9af4bc983f4d487c61ea56cc5f6. This device is marketed under the brand name Sirolimus. The license holder is CARDIOAXIS CORPORATION PVT LTD C/O FRISCH MEDICAL DEVICES PVT LTD, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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