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PTCA Non-Compliant Rapid Exchange Dilatation Balloon Catheter - India CDSCO Medical Device Registration

PTCA Non-Compliant Rapid Exchange Dilatation Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000057_5dd5bf4140b20e3e50c3c9cc65dc65d2_8fa39fea6a7cdcef2b7df880276a2814. This device is marketed under the brand name TM under process. The license holder is KAMAL ENCON INDUSTRIES LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Baddi.

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CDSCO Registered
Class Class D
PTCA Non-Compliant Rapid Exchange Dilatation Balloon Catheter
UID: MFG/MD/2019/000057_5dd5bf4140b20e3e50c3c9cc65dc65d2_8fa39fea6a7cdcef2b7df880276a2814

Brand Name

TM under process

Device Class

Class D

Approving Authority

Sub Zonal Baddi

Product Information

PTCA Non-Compliant Rapid Exchange Dilatation Balloon Catheter is indicated for: - Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion. - Balloon dilatation of a stent after implantation

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