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/2020/000472_fd4b8ea69c6295bd33f104c4d506ff3d_f1fc44729d237783addd5129e34b8a47. This device is marketed under the brand name Ultraskin. The license holder is M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Coronary Dilatation Catheter

UID: IMP/MD/2020/000472_fd4b8ea69c6295bd33f104c4d506ff3d_f1fc44729d237783addd5129e34b8a47

Brand Name

Ultraskin

License Holder

M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Mini Tadpole and Tadpole Coronary Dilatation 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 coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST segment elevation myocardial infarction • Balloon dilatation of a stent after implantation (Ultraskin)