CORONARY DILATATION CATHETER - India CDSCO Medical Device Registration

CORONARY DILATATION CATHETER is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000584_c238fe24f8f241a0ed7348748c266705_cd1540fd9fac4fc77c3ba28ac665231d. This device is marketed under the brand name NC TREK NEO™. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

CORONARY DILATATION CATHETER

UID: IMP/MD/2023/000584_c238fe24f8f241a0ed7348748c266705_cd1540fd9fac4fc77c3ba28ac665231d

Brand Name

NC TREK NEO™

License Holder

Abbott Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The NC TREK NEO™ Coronary Dilatation Catheters are indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) Balloon dilatation of a stent after implantation (NC TREK NEO™)