Dilatation and Perfusion Coronary Catheter - India CDSCO Medical Device Registration

Dilatation and Perfusion Coronary Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000188_a0f2898f493796a49ece19632de153fc_69b3b867b97c1ad0bb3eeabfdea79c37. This device is marketed under the brand name AMICATH II. The license holder is EVENT MEDI SYSTEMS, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Dilatation and Perfusion Coronary Catheter

UID: IMP/MD/2019/000188_a0f2898f493796a49ece19632de153fc_69b3b867b97c1ad0bb3eeabfdea79c37

Brand Name

AMICATH II

License Holder

EVENT MEDI SYSTEMS

Device Class

Class D

Approving Authority

CDSCO

Product Information

Amicath II is a Catheter for dilatation and perfusion of coronary lesions, particularly indicated in patients with acute myocardial infraction with acute total occlusion , suitable for percutaneous transluminal coronary angioplasty (AMICATH II) and which allow dilating the stenosed part of the acute total occlusion up to a characteristic diameter of 1.30mm, Viewing of the state of the artery any thrombus distal to the acute total occlusion, Administration of pharmacological substances for local treatment, Locating the lesion in-situ and enabling the estimation of its length if and when it is less than 40mm